ACCUPEN— 510(k) K083377

Substantially Equivalent

Accutome Ultrasound, Inc.

FDA 510(k) clearance K083377 for ACCUPEN, Substantially Equivalent on 2009-07-27. Applicant: Accutome Ultrasound, Inc..

Clearance details

Applicant: Accutome Ultrasound, Inc.
Product code: Code HKX
Advisory panel: Ophthalmic
Date received: 2008-11-14
Decision date: 2009-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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