HEARTRAK SMART ECAT— 510(k) K083535

Substantially Equivalent

Universal Medical, Inc.

FDA 510(k) clearance K083535 for HEARTRAK SMART ECAT, Substantially Equivalent on 2008-12-15. Applicant: Universal Medical, Inc..

Clearance details

Applicant: Universal Medical, Inc.
Product code: Code DXH
Advisory panel: Cardiovascular
Date received: 2008-11-28
Decision date: 2008-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ewing, NJ, US

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