COMPUMEDICS SIESTA SYSTEM— 510(k) K003175

Substantially Equivalent

Compumedics Limited

FDA 510(k) clearance K003175 for COMPUMEDICS SIESTA SYSTEM, Substantially Equivalent on 2000-12-27. Applicant: Compumedics Limited. Device class: 2.

Clearance details

Applicant: Compumedics Limited
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2000-10-10
Decision date: 2000-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis,, MN, 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.