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FDA 510(k)

INOMAX DS

K-Number: K071516 · 2007-10-03

ApplicantIno Therapeutics, LLC
Decision Date2007-10-03
Product CodeMRN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INOMAX DS is the device name listed in this FDA 510(k) record. The listed applicant is Ino Therapeutics, LLC. It received FDA 510(k) clearance on 2007-10-03 under 510(k) number K071516. 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?

INOMAX DS is a medical device that received FDA 510(k) clearance on 2007-10-03. The listed applicant is Ino Therapeutics, LLC. The 510(k) number is K071516.

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

INOMAX DS received FDA 510(k) clearance on 2007-10-03, under 510(k) number K071516.

Who is the listed applicant for INOMAX DS?

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

What is the FDA product code for INOMAX DS?

The FDA product code for INOMAX DS is MRN.

Related Clinical Trials

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.

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Other records listing Ino Therapeutics, LLC 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.

K092545INOMAX DS (DELIVERY SYSTEM), MODEL 10003K090958INOMAX DS (DELIVERY SYSTEM)K081691INOMAX DS (DELIVERY SYSTEM)K070867INOMAX DS (DELIVERY SYSTEM), MODEL 10003

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

View on FDA Database →

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

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