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FDA 510(k)

MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605

K-Number: K043006 · 2005-02-11

ApplicantRespironics, Inc.
Decision Date2005-02-11
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605 is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2005-02-11 under 510(k) number K043006. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605?

MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605 is a medical device that received FDA 510(k) clearance on 2005-02-11. The listed applicant is Respironics, Inc.. The 510(k) number is K043006.

When did MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605 receive FDA 510(k) clearance?

MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605 received FDA 510(k) clearance on 2005-02-11, under 510(k) number K043006.

Who is the listed applicant for MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605?

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

What is the FDA product code for MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605?

The FDA product code for MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605 is CAW.

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Related Devices (Code: CAW)

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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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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