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FDA 510(k)

INOMAX DS(DELIVERY SYSTEMS

K-Number: K113272 · 2012-02-29

ApplicantIno Therapeutics, LLC/Dba Ikaria
Decision Date2012-02-29
Product CodeMRN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INOMAX DS(DELIVERY SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Ino Therapeutics, LLC/Dba Ikaria. It received FDA 510(k) clearance on 2012-02-29 under 510(k) number K113272. The device is classified under product code MRN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INOMAX DS(DELIVERY SYSTEMS?

INOMAX DS(DELIVERY SYSTEMS is a medical device that received FDA 510(k) clearance on 2012-02-29. The listed applicant is Ino Therapeutics, LLC/Dba Ikaria. The 510(k) number is K113272.

When did INOMAX DS(DELIVERY SYSTEMS receive FDA 510(k) clearance?

INOMAX DS(DELIVERY SYSTEMS received FDA 510(k) clearance on 2012-02-29, under 510(k) number K113272.

Who is the listed applicant for INOMAX DS(DELIVERY SYSTEMS?

The FDA 510(k) record lists Ino Therapeutics, LLC/Dba Ikaria as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INOMAX DS(DELIVERY SYSTEMS?

The FDA product code for INOMAX DS(DELIVERY SYSTEMS is MRN.

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Other records listing Ino Therapeutics, LLC/Dba Ikaria as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K110635INOMAX DS(IR) (DELIVERY SYSTEM)

Related Devices (Code: MRN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242374ULSPIRA TS™ Nitric Oxide Therapy SystemAirgas Therapeutics, LLCK242578EVOLVE Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLCK240410EVOLVE Nitric Oxide Delivery SystemMalinckrodt Manufacturing, LLCK233251NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.K222930Evolve Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLCK231823NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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