Mask, Gas, Anesthetic

FDA product code BSJ · 51 cleared devices

Class 1 Anesthesiology

Regulation: 21 CFR 868.5550
Review panel: AN
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1979-03-01 – 2017-10-13

BSJ 2017-10-13

SuperNO2VA Device

Applicant Revolutionary Medical Devices, Inc.

K number K163277

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BSJ 1995-08-15

ANESTHESIA/RESPIRATORY FACE MASK

Applicant Medical Marketing Concepts

K number K953107

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BSJ 1995-08-11

ANESTHESIA FACE MASK

Applicant Mallinckrodt Medical

K number K953295

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BSJ 1995-07-11

BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK

Applicant Owens-Brigam Medical Co.

K number K952689

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BSJ 1995-06-07

AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK

Applicant Promedic, Inc.

K number K951043

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BSJ 1995-03-10

DISPOSABLE ADHESIVE FACE MASK

Applicant Advanced Warming Systems, Inc.

K number K950771

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BSJ 1995-01-27

MASK, GAS, ANESTHETIC

Applicant Hans Rudolph, Inc.

K number K945894

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BSJ 1994-11-08

DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK

Applicant Fvtnks

K number K945440

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BSJ 1994-10-03

DISPOSABLE, PREFORMED FACE MASK

Applicant Meridian Medical Systems, Inc.

K number K944157

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BSJ 1993-08-20

NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE

Applicant Hans Rudolph, Inc.

K number K932147

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BSJ 1993-06-22

AMBU DISPOSABLE FACE MASK

Applicant Ambu, Inc.

K number K932014

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BSJ 1992-04-08

IAS ANESTHESIA MASK

Applicant Ias

K number K915558

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BSJ 1990-09-04

VENTLAB VENT-MASK, CAT# VR 0010/20/30

Applicant Ventlab Corp.

K number K903881

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BSJ 1990-08-22

ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS

Applicant Rondex Products, Inc.

K number K902298

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BSJ 1989-08-21

ANESTHESIA/RESPIRATORY DISPOSABLE MASK

Applicant Concord/Portex

K number K891316

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BSJ 1989-08-21

MODIFIED TOUCH-ME-NOT MASK

Applicant Walt'S Products

K number K884157

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BSJ 1989-04-20

RESPIRONICS SEALEASY II

Applicant Respironics, Inc.

K number K890795

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BSJ 1989-01-24

MODIFIED CUSHION-FLEX(TM)

Applicant Life Design Systems, Inc.

K number K890108

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BSJ 1988-11-17

CUSHION FLEX(TM)

Applicant Life Design Systems, Inc.

K number K884387

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BSJ 1988-06-30

MASK, GAS, ANESTHETIC

Applicant Eastmed Enterprises, Inc.

K number K882434

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BSJ 1988-04-25

RONDEX RESCUE MASK

Applicant Rondex Products, Inc.

K number K881393

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BSJ 1988-03-24

NON CONDUCTIVE, SINGLE USE ANESTHESIA FACE MASK

Applicant Medesign, Inc.

K number K881067

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BSJ 1988-03-21

MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISP

Applicant King Systems Corp.

K number K880682

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BSJ 1987-12-21

SEALFLEX MASK

Applicant Engineered Medical Systems

K number K874746

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BSJ 1987-06-17

SPIRASEAL(TM) FACE MASK (VARIOUS SIZES)

Applicant Brigam, Inc.

K number K872015

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BSJ 1987-06-08

RIBBED CUSHION MASK

Applicant Engineered Medical Systems

K number K871851

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BSJ 1986-08-01

MP-XMO DISPOSABLE FACE MASK

Applicant Medipart Jerry Alexander

K number K862784

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BSJ 1986-08-01

MP-XMV DISPOSABLE FACE MASK

Applicant Medipart Jerry Alexander

K number K862783

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BSJ 1986-08-01

MP-XML DISPOSABLE FACE MASK

Applicant Medipart Jerry Alexander

K number K862782

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BSJ 1986-08-01

MP-XMM DISPOSABLE FACE MASK

Applicant Medipart Jerry Alexander

K number K862781

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BSJ 1986-04-30

FACEGLOV,ANESTHETIC GAS MASK

Applicant Loran , Ltd.

K number K860686

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BSJ 1985-12-03

SERIES 2000 MEDS MASK

Applicant Med Systems

K number K853785

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BSJ 1985-11-05

SUR-FIT FACE MASK

Applicant Anesthesia Respiratory Technology, Inc.

K number K854161

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BSJ 1985-03-25

PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY

Applicant Plasmedics, Inc.

K number K850263

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BSJ 1984-12-04

MEDIPART FACE MASK MP-XM

Applicant Medipart Jerry Alexander

K number K844494

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BSJ 1984-12-04

MEDIPART FACE MASK & FILTER MP-30XM

Applicant Medipart Jerry Alexander

K number K844493

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BSJ 1984-08-20

CUSHION-FLEX TM

Applicant Life Design Systems, Inc.

K number K843169

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BSJ 1984-07-06

DRYDEN INFLATABLE MASK

Applicant Dryden Corp.

K number K842472

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BSJ 1984-04-05

DISPOSABLE ANESTHESIA MASK

Applicant Hospitak, Inc.

K number K841240

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BSJ 1984-02-21

DISPOS. ANESTHESIA FACE MASK

Applicant Marquest Medical Products, Inc.

K number K840535

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BSJ 1984-02-17

PREMIUM DABM DISPOS. ANES. BREATH MASK

Applicant Ohio Medical Products

K number K840452

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BSJ 1984-01-25

CRYSTALCONE FACE MASK-MED-W/HOOKRING

Applicant Warne Surgical Products, Ltd.

K number K834536

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BSJ 1984-01-18

PAEDIATRIC FACE MASK 1-3 W/WO RING

Applicant Warne Surgical Products, Ltd.

K number K834454

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BSJ 1983-07-07

NON CONDUCTIVE ANESTHESIA FACEMASK

Applicant Vital Signs, Inc.

K number K831713

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BSJ 1983-05-09

MASKS

Applicant Medovations, Inc.

K number K830982

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BSJ 1982-04-26

NON CONDUCTIVE PEDIATRIC ANES. FACE

Applicant Vital Signs, Inc.

K number K821045

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BSJ 1981-04-23

OHIO NONCONDUCTIVE RBS TYPE FACE MASK

Applicant Ohio Medical Products

K number K810990

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BSJ 1981-01-05

NON-CONDUCTIVE ANESTHESIA FACE MASK

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K803185

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BSJ 1980-06-04

NON-CONDUCTIVE, SINGLE USE FACE MASK #55

Applicant Vital Signs, Inc.

K number K801251

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BSJ 1979-05-25

ACCUTRON POLLUTION REDUCER

Applicant Parker Laboratories, Inc.

K number K790638

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BSJ 1979-03-01

THE BLUE MASK

Applicant Collectovac, Inc.

K number K782163

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