BALANCEBACK VNG SYSTEM— 510(k) K042529

Name: FDA 510(k) clearance K042529
Creator: U.S. Food and Drug Administration
Published: 2004-10-06

Substantially Equivalent

Fall Prevention Technologies, LLC

FDA 510(k) clearance K042529 for BALANCEBACK VNG SYSTEM, Substantially Equivalent on 2004-10-06. Applicant: Fall Prevention Technologies, LLC. Device class: 2.

Clearance details

Applicant: Fall Prevention Technologies, LLC
Product code: Code GWN
Device class: Class 2
Regulation: 21 CFR 882.1460
Advisory panel: Neurology
Date received: 2004-09-17
Decision date: 2004-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

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