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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Counter-Pulsating, External
510(k) Number K042413
Device Name ACS MODEL NCP-2
Applicant
APPLIED CARDIAC SYSTEMS
22912 EL PACIFICO DR.
LAGUNA HILLS,  CA  92653
Applicant Contact R. BEN GHADIMI
Correspondent
APPLIED CARDIAC SYSTEMS
22912 EL PACIFICO DR.
LAGUNA HILLS,  CA  92653
Correspondent Contact R. BEN GHADIMI
Regulation Number870.5225
Classification Product Code
DRN  
Date Received09/07/2004
Decision Date 12/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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