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FDA 510(k)

COMPASS M10 SYSTEM

K-Number: K041724 · 2004-09-28

ApplicantMedcare Flaga
Decision Date2004-09-28
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COMPASS M10 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medcare Flaga. It received FDA 510(k) clearance on 2004-09-28 under 510(k) number K041724. 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 COMPASS M10 SYSTEM?

COMPASS M10 SYSTEM is a medical device that received FDA 510(k) clearance on 2004-09-28. The listed applicant is Medcare Flaga. The 510(k) number is K041724.

When did COMPASS M10 SYSTEM receive FDA 510(k) clearance?

COMPASS M10 SYSTEM received FDA 510(k) clearance on 2004-09-28, under 510(k) number K041724.

Who is the listed applicant for COMPASS M10 SYSTEM?

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

What is the FDA product code for COMPASS M10 SYSTEM?

The FDA product code for COMPASS M10 SYSTEM is MNR.

Related Clinical Trials

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Other records listing Medcare Flaga 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.

K043132UNIVERSAL XACTTRACEK041904COMPASS F10 SYSTEMK024322EMBLA N7000

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

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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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