Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

FDA product code CCQ · 62 cleared devices

Class 1 Anesthesiology

Regulation: 21 CFR 868.5640
Review panel: AN
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-09-21 – 1997-09-23

CCQ 1997-09-23

EZ SPRAY

Applicant Intertex Research, Inc.

K number K972397

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CCQ 1997-04-23

E-Z SPACER MASK (SMALL)

Applicant Airpharma, LLC

K number K964956

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CCQ 1996-08-14

MDI TUTOR

Applicant Mdi Tutor, Inc.

K number K961894

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CCQ 1996-07-25

MEDSHIELD/AEROCHAMBER

Applicant Diemolding Corp.

K number K961455

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CCQ 1996-05-10

SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100

Applicant Aradigm Corp.

K number K960593

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CCQ 1992-07-21

SALINE SOLUTION- STERILE

Applicant Trinity Laboratories, Inc.

K number K922033

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CCQ 1991-05-13

MODIFIED AEROCHAMBER WITH MASK

Applicant Monaghan Medical Corp.

K number K900576

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CCQ 1991-04-10

MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER

Applicant Monaghan Medical Corp.

K number K900557

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CCQ 1990-05-18

FRANK INHALER THERMAL S

Applicant Buttner-Frank GmbH

K number K895115

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CCQ 1990-04-16

EVOLUTION ULTRASONIC

Applicant Medical Industries America, Inc.

K number K894215

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CCQ 1990-01-24

PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED

Applicant Dura Pharmaceuticals, Inc.

K number K894555

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CCQ 1990-01-17

PFEIFFER METERED DOSAGE SYSTEM

Applicant Syva Co.

K number K896070

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CCQ 1989-11-21

FREEWAY NEBULIZER COMPRESSOR

Applicant Lifecare Services, Inc.

K number K895592

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CCQ 1989-10-13

DEVILBISS MODEL 6610D

Applicant Devilbiss Health Care, Inc.

K number K894441

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CCQ 1989-10-06

DEVILBISS MODEL 8500D AND 8500D-608

Applicant Devilbiss Health Care, Inc.

K number K894244

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CCQ 1989-06-23

GENTLEHALER(R)

Applicant Schering Research

K number K892117

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CCQ 1988-01-22

DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP

Applicant Dey Laboratories, Inc.

K number K875024

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CCQ 1988-01-22

DEY-PAK PURIFIED WATER, USP, STERILE

Applicant Dey Laboratories, Inc.

K number K875011

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CCQ 1987-12-30

MONAGHAN AEROCHAMBER WITH MASK

Applicant Monaghan Medical Corp.

K number K874513

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CCQ 1987-10-13

INSPIREASE(R), DRUG DELIVERY SYSTEM

Applicant Key Pharmaceuticals, Inc.

K number K873793

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CCQ 1987-10-09

INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN)

Applicant Vortran Medical Technology 1, Inc.

K number K873477

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CCQ 1987-09-11

MISTMASTER

Applicant Sonora Respiratory Products, Inc.

K number K872315

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CCQ 1987-05-15

THE SPIRA ELEKTRO 2

Applicant Warren E. Collins, Inc.

K number K871151

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CCQ 1987-04-01

PREFILLED RESPIRATORY THERAPY VIALS

Applicant Automatic Liquid Packaging, Inc.

K number K870332

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CCQ 1987-03-16

CHALLENGER DOSIMETER

Applicant Salter Labs

K number K870755

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CCQ 1987-03-16

HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER

Applicant Salter Labs

K number K870027

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CCQ 1986-03-27

ROSENTHAL-FRENCH NEBULIZATION DOSIMETER

Applicant Laboratory For Applied Immunology, Inc.

K number K860800

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CCQ 1986-03-20

CIRRUS DRUG NEBULIZER MK III

Applicant Dhd Medical Products Div. Diemolding Corp.

K number K860875

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CCQ 1986-01-28

CIRRUS NEBULIZER-DELUXE KIT

Applicant Dhd Medical Products Div. Diemolding Corp.

K number K854952

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CCQ 1985-12-19

MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S

Applicant Medipart Jerry Alexander

K number K854551

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CCQ 1985-12-19

MEDIPART REMOTE INJECTION SYS FOR ULTRAVENT RADIOA

Applicant Medipart Jerry Alexander

K number K854550

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CCQ 1985-12-09

PULMO-AIDE MODEL 5610D

Applicant The Devilbiss Co.

K number K854520

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CCQ 1985-09-26

MAXI-NEB

Applicant Ashai Co. , Ltd.

K number K852627

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CCQ 1985-08-29

SYNCHRONER TM (PROPOSED TRADENAME)

Applicant Fisons Corp.

K number K853350

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CCQ 1985-08-29

MEDIX ELECTRONIC NEBULIZING SYSTEM

Applicant Medix Corp.

K number K853071

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CCQ 1985-08-08

PFEIFFER PUMP

Applicant Ing. Erich Pfeiffer GmbH & Co. Kg.

K number K851525

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CCQ 1985-06-18

MICRO-INHALER MODEL TV-7000 & TV-8000

Applicant Bioclimatic, Inc.

K number K851254

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CCQ 1985-05-23

MICRON ONE PORTA. ULTRASONIC NEBULIZER

Applicant Endotek Development Laboratories

K number K850926

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CCQ 1984-12-13

MIST-EASE NEBULIZER

Applicant General Physiotherapy, Inc.

K number K844591

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CCQ 1984-08-17

AVA-NEB NEBULIZER

Applicant Avatron, Inc.

K number K843102

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CCQ 1984-08-07

VMT GENTLE-HALER

Applicant Vortran Medical Technology 1, Inc.

K number K842988

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CCQ 1984-07-27

ARM-A-CARE HUMIDIFIER-RESPIRATORY GAS

Applicant Armour Pharmaceutical Co.

K number K841991

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CCQ 1984-07-27

ARM-A-CARE NEBULIZER-NEBULIZER

Applicant Armour Pharmaceutical Co.

K number K841990

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CCQ 1984-07-27

ARM-A-VIAL LV SODIUM CHLORIDE INHALAT

Applicant Armour Pharmaceutical Co.

K number K841989

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CCQ 1984-07-27

ARM-A-VIAL LV SODIUM, CHLORIDE INHALAT

Applicant Armour Pharmaceutical Co.

K number K841988

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CCQ 1984-07-27

ARM-A-VIAL LV STERIAL WATER FOR INHALA

Applicant Armour Pharmaceutical Co.

K number K841987

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CCQ 1984-06-25

CROUP TENT FRAME

Applicant Home Run Treadmill Co.

K number K842192

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CCQ 1984-06-05

VMT HAND HELD NEBULIZER

Applicant Vortran Medical Technology 1, Inc.

K number K841894

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CCQ 1984-04-24

MISTY OX DISPOS. NEBULIZER

Applicant Medical Molding Corp. of America

K number K841469

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CCQ 1984-04-13

AIR-NEB NEBULIZER COMPRESSOR UNIT

Applicant Airmed Corp.

K number K841321

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CCQ 1983-12-27

VIRALIZER NEBULIZER SPRAYER

Applicant Viral Response System, Inc.

K number K833474

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CCQ 1983-08-16

INSPIREASE

Applicant Key Pharmaceuticals, Inc.

K number K832037

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CCQ 1982-12-15

NEBULIZER CHRONOLOG & INTERPRETER

Applicant Advanced Technology Products, Inc.

K number K823423

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CCQ 1982-10-13

SYNTEVENT ATOMIZER/NEBULIZER AEROSOL

Applicant Syva Co.

K number K822625

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CCQ 1981-09-24

BOSCH HEARING INSTRUMENTS

Applicant Retlif, Inc.

K number K812503

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CCQ 1981-06-09

TRAVELAIRE

Applicant B & F Medical Products, Inc.

K number K811404

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CCQ 1981-03-17

NEBULIZERS

Applicant Todd Industries, Inc.

K number K810343

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CCQ 1980-10-03

SHERWOOD NANO-MIST NEBULIZER W/MOUTHPIEC

Applicant Sherwood Medical Co.

K number K802281

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CCQ 1980-04-24

MISER INHALATION DEVICE, PART NO. 700

Applicant Vix Breathing Equipment Co.

K number K800763

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CCQ 1978-10-16

DISPOSABLE INCENTIVE SPIROMETER

Applicant Inhal-O-Tech Medical Plastic

K number K781394

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CCQ 1978-09-27

PULMO-SONIC

Applicant The Devilbiss Co.

K number K781073

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CCQ 1976-09-21

DRUG NEBULIZER

Applicant Ohio Medical Products

K number K760580

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