SOMNOWATCH— 510(k) K081485

Substantially Equivalent

Somnomedics GmbH

FDA 510(k) clearance K081485 for SOMNOWATCH, Substantially Equivalent on 2008-09-18. Applicant: Somnomedics GmbH. Device class: 2.

Clearance details

Applicant: Somnomedics GmbH
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2008-05-28
Decision date: 2008-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alexandria, VA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.