FOCUSCOPE UNIVERSAL SYSTEM— 510(k) K843900

Name: FDA 510(k) clearance K843900
Creator: U.S. Food and Drug Administration
Published: 1984-12-06

Substantially Equivalent

Medical Diagnostics, Ca.

FDA 510(k) clearance K843900 for FOCUSCOPE UNIVERSAL SYSTEM, Substantially Equivalent on 1984-12-06. Applicant: Medical Diagnostics, Ca.. Device class: 2.

Clearance details

Applicant: Medical Diagnostics, Ca.
Product code: Code GDB
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1984-10-03
Decision date: 1984-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valrico, FL, US

Download summary PDF View on FDA.gov ↗

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