COMPUMEDICS SOMTE SYSTEM— 510(k) K021176

Substantially Equivalent

Compumedics Limited

FDA 510(k) clearance K021176 for COMPUMEDICS SOMTE SYSTEM, Substantially Equivalent on 2003-01-21. 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
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Minneapolis,, MN, US
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