HEART ACCESS PLUS CARDIAC EVENT RECORDER— 510(k) K973141

Substantially Equivalent

Paceart, Inc.

FDA 510(k) clearance K973141 for HEART ACCESS PLUS CARDIAC EVENT RECORDER, Substantially Equivalent on 1997-11-12. Applicant: Paceart, Inc..

Clearance details

Applicant: Paceart, Inc.
Product code: Code DXH
Advisory panel: Cardiovascular
Date received: 1997-08-21
Decision date: 1997-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hasbrouck Heights, NJ, US

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