P.H.D. - PERSONAL HEART DEVICE MODEL 5258— 510(k) K963904

Substantially Equivalent

Heart Alert, Inc.

FDA 510(k) clearance K963904 for P.H.D. - PERSONAL HEART DEVICE MODEL 5258, Substantially Equivalent on 1997-05-15. Applicant: Heart Alert, Inc..

Clearance details

Applicant: Heart Alert, Inc.
Product code: Code DXH
Advisory panel: Cardiovascular
Date received: 1996-09-30
Decision date: 1997-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Douglasville, GA, US

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