VITALITY SYSTEM— 510(k) K993143

Substantially Equivalent

Soma Blue, Inc.

FDA 510(k) clearance K993143 for VITALITY SYSTEM, Substantially Equivalent on 1999-12-27. Applicant: Soma Blue, Inc.. Device class: 2.

Clearance details

Applicant: Soma Blue, Inc.
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 1999-09-21
Decision date: 1999-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Augusta, GA, US

Download summary PDF View on FDA.gov ↗

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