HEARTRAK AF— 510(k) K071130

Substantially Equivalent

Universal Medical, Inc.

FDA 510(k) clearance K071130 for HEARTRAK AF, Substantially Equivalent on 2008-05-14. Applicant: Universal Medical, Inc..

Clearance details

Applicant: Universal Medical, Inc.
Product code: Code DXH
Advisory panel: Cardiovascular
Date received: 2007-04-23
Decision date: 2008-05-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Ewing, NJ, US

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