ETUDE, URODYNAMIC INVESTIGATION SYSTEM— 510(k) K901494

Name: FDA 510(k) clearance K901494
Creator: U.S. Food and Drug Administration
Published: 1990-10-26

Substantially Equivalent

Dantec Medical, Inc.

FDA 510(k) clearance K901494 for ETUDE, URODYNAMIC INVESTIGATION SYSTEM, Substantially Equivalent on 1990-10-26. Applicant: Dantec Medical, Inc.. Device class: 2.

Clearance details

Applicant: Dantec Medical, Inc.
Product code: Code FAP
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1990-03-29
Decision date: 1990-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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