URDYN 5000 (UROFLOWMETER)— 510(k) K860368

Name: FDA 510(k) clearance K860368
Creator: U.S. Food and Drug Administration
Published: 1986-04-23

Substantially Equivalent

Dantec Electronics, Inc.

FDA 510(k) clearance K860368 for URDYN 5000 (UROFLOWMETER), Substantially Equivalent on 1986-04-23. Applicant: Dantec Electronics, Inc.. Device class: 1.

Clearance details

Applicant: Dantec Electronics, Inc.
Product code: Code FFO
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 1986-02-03
Decision date: 1986-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

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