Apparatus, Nitric Oxide Delivery

FDA product code MRN · 31 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.5165
Review panel: AN
Implant: No
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 2000-02-10 – 2025-01-17

MRN 2025-01-17

ULSPIRA TS™ Nitric Oxide Therapy System

Applicant Airgas Therapeutics, LLC

K number K242374

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MRN 2025-01-03

EVOLVE Nitric Oxide Delivery System

Applicant Mallinckrodt Manufacturing, LLC

K number K242578

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MRN 2024-05-28

EVOLVE Nitric Oxide Delivery System

Applicant Malinckrodt Manufacturing, LLC

K number K240410

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MRN 2024-05-23

NOxBOXi Nitric Oxide Delivery System

Applicant Linde Gas & Equipment, Inc.

K number K233251

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MRN 2023-12-06

Evolve Nitric Oxide Delivery System

Applicant Mallinckrodt Manufacturing, LLC

K number K222930

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MRN 2023-08-11

NOxBOXi Nitric Oxide Delivery System

Applicant Linde Gas & Equipment, Inc.

K number K231823

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MRN 2023-06-30

Ulspira TS Nitric Oxide Therapy System

Applicant Airgas Therapeutics

K number K212409

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MRN 2023-04-20

Inomax DSIR

Applicant Mallinckrodt Manufacturing, LLC

K number K211153

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MRN 2022-04-27

NOxBOXi Nitric Oxide Delivery System

Applicant Linde Gas & Equipment, Inc.

K number K220898

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MRN 2020-06-19

The NOxBOXi Nitric Oxide Delivery System

Applicant Praxair, Inc.

K number K201339

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MRN 2020-06-17

INOmax DSIR Plus

Applicant Mallinckrodt Manufacturing, LLC

K number K200389

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MRN 2020-03-10

AeroNOx 2.0 Nitric Oxide Titration & Monitoring System

Applicant International Biomedical

K number K193481

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MRN 2018-10-02

NOxBOXi Nitric Oxide Delivery System

Applicant Praxair Distribution, Inc.

K number K171696

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MRN 2013-11-29

INOMAX DSIR (DELIVERY SYSTEM)

Applicant Ino Therapeutics/Ikaria

K number K131686

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MRN 2013-05-02

INOMAX DSIR (DELIVERY SYSTEM)

Applicant Ino Therapeutics

K number K130605

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MRN 2012-09-24

INOMAX DS (DELIVERY SYSTEM)

Applicant Ino Therapeutics

K number K121021

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MRN 2012-05-16

GENOSYL MV-1000

Applicant Geno, LLC

K number K120216

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MRN 2012-02-29

INOMAX DS(DELIVERY SYSTEMS

Applicant Ino Therapeutics, LLC/Dba Ikaria

K number K113272

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MRN 2011-06-24

INOMAX DSIR (DELIVERY SYSTEM)

Applicant Ino Therapeutics

K number K110344

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MRN 2011-06-23

INOMAX DS(IR) (DELIVERY SYSTEM)

Applicant Ino Therapeutics, LLC/Dba Ikaria

K number K110635

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MRN 2010-04-15

INOMAX DS

Applicant Ino Therapeutics

K number K093922

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MRN 2010-03-10

INOMAX DS (DELIVERY SYSTEM), MODEL 10003

Applicant Ino Therapeutics, LLC

K number K092545

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MRN 2009-12-16

AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM

Applicant International Biomedical, Ltd.

K number K093260

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MRN 2008-08-28

INOMAX DS (DELIVERY SYSTEM)

Applicant Ino Therapeutics, LLC

K number K081691

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MRN 2008-08-06

INOMAX DS (DELIVERY SYSTEM), MODEL 10003

Applicant Ino Therapeutics

K number K080484

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MRN 2007-10-03

INOMAX DS

Applicant Ino Therapeutics, LLC

K number K071516

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MRN 2007-04-27

INOMAX DS (DELIVERY SYSTEM), MODEL 10003

Applicant Ino Therapeutics, LLC

K number K070867

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MRN 2006-12-14

INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003

Applicant Ino Therapeutics

K number K061901

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MRN 2004-01-26

VIANOX DELIVERY SYSTEM, MODEL II

Applicant Pulmonox Medical, Inc.

K number K033779

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MRN 2000-08-04

AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002

Applicant Pulmonox Medical Corp.

K number K000653

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MRN 2000-02-10

DATEX-OHMEDA INOVENT DELIVERY SYSTEM

Applicant Datex-Ohmeda

K number K000186

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