DANTEC DUET— 510(k) K960503

Substantially Equivalent

Dantec Medical, Inc.

FDA 510(k) clearance K960503 for DANTEC DUET, Substantially Equivalent on 1996-09-16. Applicant: Dantec Medical, Inc.. Device class: 2.

Clearance details

Applicant: Dantec Medical, Inc.
Product code: Code FEN
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1996-02-02
Decision date: 1996-09-16
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.