UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1— 510(k) K083679

Name: FDA 510(k) clearance K083679
Creator: U.S. Food and Drug Administration
Published: 2009-09-11

Substantially Equivalent

Uroval

FDA 510(k) clearance K083679 for UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1, Substantially Equivalent on 2009-09-11. Applicant: Uroval. Device class: 2.

Clearance details

Applicant: Uroval
Product code: Code IKN
Device class: Class 2
Regulation: 21 CFR 890.1375
Advisory panel: Physical Medicine
Date received: 2008-12-11
Decision date: 2009-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.