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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K920020
Device Name CARDIO-CARD ECG MANAGEMENT SYSTEM
Applicant
Nasiff Assoc., Inc.
P.O. Box 88
Brewerton,  NY  13029
Applicant Contact ROGER NASIFF
Correspondent
Nasiff Assoc., Inc.
P.O. Box 88
Brewerton,  NY  13029
Correspondent Contact ROGER NASIFF
Regulation Number870.2340
Classification Product Code
DPS  
Date Received01/02/1992
Decision Date 07/09/1992
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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