WOUND MEASURING & MONITORING DEVICE— 510(k) K131596

Name: FDA 510(k) clearance K131596
Creator: U.S. Food and Drug Administration
Published: 2013-12-11

Substantially Equivalent

Woundvision, LLC

FDA 510(k) clearance K131596 for WOUND MEASURING & MONITORING DEVICE, Substantially Equivalent on 2013-12-11. Applicant: Woundvision, LLC. Device class: 1.

Clearance details

Applicant: Woundvision, LLC
Product code: Code FXN
Device class: Class 1
Regulation: 21 CFR 878.4160
Advisory panel: General, Plastic Surgery
Date received: 2013-06-03
Decision date: 2013-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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