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FDA 510(k)

DATEX-OHMEDA INOVENT DELIVERY SYSTEM

K-Number: K000186 · 2000-02-10

ApplicantDatex-Ohmeda
Decision Date2000-02-10
Product CodeMRN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DATEX-OHMEDA INOVENT DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Datex-Ohmeda. It received FDA 510(k) clearance on 2000-02-10 under 510(k) number K000186. 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 DATEX-OHMEDA INOVENT DELIVERY SYSTEM?

DATEX-OHMEDA INOVENT DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2000-02-10. The listed applicant is Datex-Ohmeda. The 510(k) number is K000186.

When did DATEX-OHMEDA INOVENT DELIVERY SYSTEM receive FDA 510(k) clearance?

DATEX-OHMEDA INOVENT DELIVERY SYSTEM received FDA 510(k) clearance on 2000-02-10, under 510(k) number K000186.

Who is the listed applicant for DATEX-OHMEDA INOVENT DELIVERY SYSTEM?

The FDA 510(k) record lists Datex-Ohmeda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DATEX-OHMEDA INOVENT DELIVERY SYSTEM?

The FDA product code for DATEX-OHMEDA INOVENT DELIVERY SYSTEM is MRN.

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Related Devices (Code: MRN)

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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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