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FDA 510(k)

CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION

K-Number: K113111 · 2011-12-08

ApplicantInovo, Inc.
Decision Date2011-12-08
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION is the device name listed in this FDA 510(k) record. The listed applicant is Inovo, Inc.. It received FDA 510(k) clearance on 2011-12-08 under 510(k) number K113111. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION?

CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION is a medical device that received FDA 510(k) clearance on 2011-12-08. The listed applicant is Inovo, Inc.. The 510(k) number is K113111.

When did CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION receive FDA 510(k) clearance?

CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION received FDA 510(k) clearance on 2011-12-08, under 510(k) number K113111.

Who is the listed applicant for CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION?

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

What is the FDA product code for CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION?

The FDA product code for CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION is NFB.

Related Clinical Trials

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Other records listing Inovo, Inc. 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.

K103392CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVERK060751INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATORK051540INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATORK031983INOVO, INC, ECONOMIZER CONSERVING REGULATOR

Related Devices (Code: NFB)

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.

K250322Respond OC Conserving Regulator (130-0800)Responsive RespiratoryK220591ProximaDynasthetics, LLCK221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLCK200401ApogeeIncoba Ltd D/B/A DynarisK151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter LabsK131023THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMENMedical Products, LLC

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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