DEVILBISS SLEEP RECORDER MODEL # RM60— 510(k) K012437

Name: FDA 510(k) clearance K012437
Creator: U.S. Food and Drug Administration
Published: 2002-07-16

Substantially Equivalent

Sunrise Medical Hhg, Inc.

FDA 510(k) clearance K012437 for DEVILBISS SLEEP RECORDER MODEL # RM60, Substantially Equivalent on 2002-07-16. Applicant: Sunrise Medical Hhg, Inc.. Device class: 2.

Clearance details

Applicant: Sunrise Medical Hhg, Inc.
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2001-07-31
Decision date: 2002-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, PA, US

Download summary PDF View on FDA.gov ↗

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