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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K962854
Device Name HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT
Applicant
Cardio Control BV
1870 The Exchange
Suite 150
Atlanta,  GA  30339
Applicant Contact MENNO ROOS
Correspondent
Cardio Control BV
1870 The Exchange
Suite 150
Atlanta,  GA  30339
Correspondent Contact MENNO ROOS
Classification Product Code
LOS
Date Received07/22/1996
Decision Date 01/27/1997
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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