URODYN 1000— 510(k) K853119

Substantially Equivalent

Dantec Electronics, Inc.

FDA 510(k) clearance K853119 for URODYN 1000, Substantially Equivalent on 1985-10-04. 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: 1985-07-25
Decision date: 1985-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.