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FDA 510(k)

EMBLA N7000

K-Number: K024322 · 2003-10-27

ApplicantMedcare Flaga
Decision Date2003-10-27
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EMBLA N7000 is the device name listed in this FDA 510(k) record. The listed applicant is Medcare Flaga. It received FDA 510(k) clearance on 2003-10-27 under 510(k) number K024322. 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 EMBLA N7000?

EMBLA N7000 is a medical device that received FDA 510(k) clearance on 2003-10-27. The listed applicant is Medcare Flaga. The 510(k) number is K024322.

When did EMBLA N7000 receive FDA 510(k) clearance?

EMBLA N7000 received FDA 510(k) clearance on 2003-10-27, under 510(k) number K024322.

Who is the listed applicant for EMBLA N7000?

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 EMBLA N7000?

The FDA product code for EMBLA N7000 is MNR.

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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 XACTTRACEK041724COMPASS M10 SYSTEMK041904COMPASS F10 SYSTEM

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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