COMPUMEDICS SOMTE PSG RECORDING SYSTEM— 510(k) K072201

Name: FDA 510(k) clearance K072201
Creator: U.S. Food and Drug Administration
Published: 2008-04-14

Substantially Equivalent

Compumedics Limited

FDA 510(k) clearance K072201 for COMPUMEDICS SOMTE PSG RECORDING SYSTEM, Substantially Equivalent on 2008-04-14. Applicant: Compumedics Limited. Device class: 2.

Clearance details

Applicant: Compumedics Limited
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2007-08-08
Decision date: 2008-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, Victoria, AU

Download summary PDF View on FDA.gov ↗

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