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FDA 510(k)

DEVILBISS SLEEP RECORDER MODEL # RM60

K-Number: K012437 · 2002-07-16

ApplicantSunrise Medical Hhg, Inc.
Decision Date2002-07-16
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DEVILBISS SLEEP RECORDER MODEL # RM60 is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Medical Hhg, Inc.. It received FDA 510(k) clearance on 2002-07-16 under 510(k) number K012437. 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 DEVILBISS SLEEP RECORDER MODEL # RM60?

DEVILBISS SLEEP RECORDER MODEL # RM60 is a medical device that received FDA 510(k) clearance on 2002-07-16. The listed applicant is Sunrise Medical Hhg, Inc.. The 510(k) number is K012437.

When did DEVILBISS SLEEP RECORDER MODEL # RM60 receive FDA 510(k) clearance?

DEVILBISS SLEEP RECORDER MODEL # RM60 received FDA 510(k) clearance on 2002-07-16, under 510(k) number K012437.

Who is the listed applicant for DEVILBISS SLEEP RECORDER MODEL # RM60?

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

What is the FDA product code for DEVILBISS SLEEP RECORDER MODEL # RM60?

The FDA product code for DEVILBISS SLEEP RECORDER MODEL # RM60 is MNR.

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Other records listing Sunrise Medical Hhg, 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.

K083249QUICKIE RHYTHMK020329DEVILBISS PD1000K020900DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEMK011229DEVILBISS 9000 SERIES CPAP, MODEL 9001K003626DEVILBISS HUMIDIFIERK993492DEVILBISS NEBULIZER MODEL 800

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Related Devices (Code: MNR)

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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

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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