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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K960544
Device Name CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM
Applicant
Nasiff Assoc., Inc.
9422 Lebeau Ln.
P.O. Box 88
Brewerton,  NY  13029
Applicant Contact ROGER E NASIFF
Correspondent
Nasiff Assoc., Inc.
9422 Lebeau Ln.
P.O. Box 88
Brewerton,  NY  13029
Correspondent Contact ROGER E NASIFF
Regulation Number870.2300
Classification Product Code
DRT  
Date Received02/07/1996
Decision Date 08/07/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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