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FDA 510(k)

INOMAX DS (DELIVERY SYSTEM)

K-Number: K090958 · 2009-06-18

ApplicantIno Therapeutics, LLC
Decision Date2009-06-18
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INOMAX DS (DELIVERY SYSTEM) 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 2009-06-18 under 510(k) number K090958. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INOMAX DS (DELIVERY SYSTEM)?

INOMAX DS (DELIVERY SYSTEM) is a medical device that received FDA 510(k) clearance on 2009-06-18. The listed applicant is Ino Therapeutics, LLC. The 510(k) number is K090958.

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

INOMAX DS (DELIVERY SYSTEM) received FDA 510(k) clearance on 2009-06-18, under 510(k) number K090958.

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

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 (DELIVERY SYSTEM)?

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

Related Clinical Trials

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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 10003K081691INOMAX DS (DELIVERY SYSTEM)K071516INOMAX DSK070867INOMAX DS (DELIVERY SYSTEM), MODEL 10003

Related Devices (Code: MNR)

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.

K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbHK254042WatchPAT SWItamar Medical , Ltd.K260050WRAP SystemHuneo, LLCK253148RX-1 SleepVivaquant, Inc. Dba Rhythm ExpressK252628CASSIEWesper, Inc.K252497SANSA HSATHuxley Medical

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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