SLEEPSCREEN/APNOESCREEN CARDIO— 510(k) K021138

Name: FDA 510(k) clearance K021138
Creator: U.S. Food and Drug Administration
Published: 2003-02-12

Substantially Equivalent

Erich Jaeger GmbH

FDA 510(k) clearance K021138 for SLEEPSCREEN/APNOESCREEN CARDIO, Substantially Equivalent on 2003-02-12. Applicant: Erich Jaeger GmbH. Device class: 2.

Clearance details

Applicant: Erich Jaeger GmbH
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2002-04-09
Decision date: 2003-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda, CA, US

Download summary PDF View on FDA.gov ↗

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