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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 K903722
Device Name MICROMED QRS CARD
Applicant
Nasiff Assoc., Inc.
P.O. Box 88
Brewerton,  NY  13029
Applicant Contact ROGER E NASIFF
Correspondent
Nasiff Assoc., Inc.
P.O. Box 88
Brewerton,  NY  13029
Correspondent Contact ROGER E NASIFF
Regulation Number870.2340
Classification Product Code
DPS  
Date Received08/15/1990
Decision Date 12/05/1990
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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