ERIS URO-DIAGNOSTIC SYSTEM— 510(k) K850169

Name: FDA 510(k) clearance K850169
Creator: U.S. Food and Drug Administration
Published: 1985-04-22

Substantially Equivalent

Eris Medical Technology

FDA 510(k) clearance K850169 for ERIS URO-DIAGNOSTIC SYSTEM, Substantially Equivalent on 1985-04-22. Applicant: Eris Medical Technology. Device class: 2.

Clearance details

Applicant: Eris Medical Technology
Product code: Code FFG
Device class: Class 2
Regulation: 21 CFR 876.1800
Advisory panel: Gastroenterology, Urology
Date received: 1985-01-16
Decision date: 1985-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Providence, NJ, US

Download summary PDF View on FDA.gov ↗

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