BioniCare Hand System— 510(k) K142236

Name: FDA 510(k) clearance K142236
Creator: U.S. Food and Drug Administration
Published: 2015-03-23

Substantially Equivalent

Vision Quest Industries, Inc.

FDA 510(k) clearance K142236 for BioniCare Hand System, Substantially Equivalent on 2015-03-23. Applicant: Vision Quest Industries, Inc.. Device class: 2.

Clearance details

Applicant: Vision Quest Industries, Inc.
Product code: Code NYN
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2014-08-13
Decision date: 2015-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, US

Download summary PDF View on FDA.gov ↗

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