PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0— 510(k) K130165

Name: FDA 510(k) clearance K130165
Creator: U.S. Food and Drug Administration
Published: 2013-08-30

Substantially Equivalent

Advanced Planimetric Services, LLC

FDA 510(k) clearance K130165 for PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0, Substantially Equivalent on 2013-08-30. Applicant: Advanced Planimetric Services, LLC. Device class: 1.

Clearance details

Applicant: Advanced Planimetric Services, LLC
Product code: Code FXN
Device class: Class 1
Regulation: 21 CFR 878.4160
Advisory panel: General, Plastic Surgery
Date received: 2013-01-23
Decision date: 2013-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elmwood Park, NJ, US

Download summary PDF View on FDA.gov ↗

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