PROSCOPES AND ADSCOPES— 510(k) K935944

Name: FDA 510(k) clearance K935944
Creator: U.S. Food and Drug Administration
Published: 1994-03-03

Substantially Equivalent

American Diagnostic Corp.

FDA 510(k) clearance K935944 for PROSCOPES AND ADSCOPES, Substantially Equivalent on 1994-03-03. Applicant: American Diagnostic Corp.. Device class: 1.

Clearance details

Applicant: American Diagnostic Corp.
Product code: Code LDE
Device class: Class 1
Regulation: 21 CFR 870.1875
Advisory panel: Cardiovascular
Date received: 1993-12-13
Decision date: 1994-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Babylon, NY, US

Download summary PDF View on FDA.gov ↗

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