ISOTRON III— 510(k) K941815

Name: FDA 510(k) clearance K941815
Creator: U.S. Food and Drug Administration
Published: 1995-05-03

Substantially Equivalent for Some Indications

Excel Tech. , Ltd.

FDA 510(k) clearance K941815 for ISOTRON III, Substantially Equivalent for Some Indications on 1995-05-03. Applicant: Excel Tech. , Ltd.. Device class: 2.

Clearance details

Applicant: Excel Tech. , Ltd.
Product code: Code LIH
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1994-04-12
Decision date: 1995-05-03
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Oakville,Ontario, CA

Download summary PDF View on FDA.gov ↗

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