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FDA 510(k)

SLEEPSCREEN/APNOESCREEN CARDIO

K-Number: K021138 · 2003-02-12

ApplicantErich Jaeger GmbH
Decision Date2003-02-12
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SLEEPSCREEN/APNOESCREEN CARDIO is the device name listed in this FDA 510(k) record. The listed applicant is Erich Jaeger GmbH. It received FDA 510(k) clearance on 2003-02-12 under 510(k) number K021138. 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 SLEEPSCREEN/APNOESCREEN CARDIO?

SLEEPSCREEN/APNOESCREEN CARDIO is a medical device that received FDA 510(k) clearance on 2003-02-12. The listed applicant is Erich Jaeger GmbH. The 510(k) number is K021138.

When did SLEEPSCREEN/APNOESCREEN CARDIO receive FDA 510(k) clearance?

SLEEPSCREEN/APNOESCREEN CARDIO received FDA 510(k) clearance on 2003-02-12, under 510(k) number K021138.

Who is the listed applicant for SLEEPSCREEN/APNOESCREEN CARDIO?

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

What is the FDA product code for SLEEPSCREEN/APNOESCREEN CARDIO?

The FDA product code for SLEEPSCREEN/APNOESCREEN CARDIO is MNR.

Related Clinical Trials

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Other records listing Erich Jaeger GmbH 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.

K023120OXYCON MOBILEK023796MS PAED-BABY BODYK001502AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PROK000648SPIRO PRO

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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