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FDA 510(k)

INOMAX DS(IR) (DELIVERY SYSTEM)

K-Number: K110635 · 2011-06-23

ApplicantIno Therapeutics, LLC/Dba Ikaria
Decision Date2011-06-23
Product CodeMRN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INOMAX DS(IR) (DELIVERY SYSTEM) 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 2011-06-23 under 510(k) number K110635. 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(IR) (DELIVERY SYSTEM)?

INOMAX DS(IR) (DELIVERY SYSTEM) is a medical device that received FDA 510(k) clearance on 2011-06-23. The listed applicant is Ino Therapeutics, LLC/Dba Ikaria. The 510(k) number is K110635.

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

INOMAX DS(IR) (DELIVERY SYSTEM) received FDA 510(k) clearance on 2011-06-23, under 510(k) number K110635.

Who is the listed applicant for INOMAX DS(IR) (DELIVERY SYSTEM)?

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(IR) (DELIVERY SYSTEM)?

The FDA product code for INOMAX DS(IR) (DELIVERY SYSTEM) 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.

K113272INOMAX DS(DELIVERY SYSTEMS

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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