SKINTELL— 510(k) K132800

Substantially Equivalent

Agfa Healthcare N.V.

FDA 510(k) clearance K132800 for SKINTELL, Substantially Equivalent on 2014-03-03. Applicant: Agfa Healthcare N.V..

Clearance details

Applicant: Agfa Healthcare N.V.
Product code: Code NQQ
Advisory panel: Radiology
Date received: 2013-09-06
Decision date: 2014-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenville, SC, US

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