TABATABA COTESTER— 510(k) K080278

Substantially Equivalent

Fim Medical

FDA 510(k) clearance K080278 for TABATABA COTESTER, Substantially Equivalent on 2008-11-28. Applicant: Fim Medical. Device class: 2.

Clearance details

Applicant: Fim Medical
Product code: Code CCJ
Device class: Class 2
Regulation: 21 CFR 868.1430
Advisory panel: Anesthesiology
Date received: 2008-02-04
Decision date: 2008-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, 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.