URODYNAMIC ANALYSIS MODULE— 510(k) K963330

Name: FDA 510(k) clearance K963330
Creator: U.S. Food and Drug Administration
Published: 1997-04-03

Substantially Equivalent

Synectics Medical, Inc.

FDA 510(k) clearance K963330 for URODYNAMIC ANALYSIS MODULE, Substantially Equivalent on 1997-04-03. Applicant: Synectics Medical, Inc.. Device class: 2.

Clearance details

Applicant: Synectics Medical, Inc.
Product code: Code FAP
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1996-08-23
Decision date: 1997-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: S-116 28 Stockholm, SE

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