VivaScope System— 510(k) K180162

Name: FDA 510(k) clearance K180162
Creator: U.S. Food and Drug Administration
Published: 2018-05-03

Substantially Equivalent

Caliber Imaging & Diagnostics, Inc.

FDA 510(k) clearance K180162 for VivaScope System, Substantially Equivalent on 2018-05-03. Applicant: Caliber Imaging & Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Caliber Imaging & Diagnostics, Inc.
Product code: Code PSN
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2018-01-19
Decision date: 2018-05-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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