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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 K914762
Device Name MICRO MED INC. QRS-CARD(TM) OFFICE ECG MONITOR
Applicant
Micromed
3508 Market St.
Philadelphia,  PA  19104
Applicant Contact SALEEM HASAN
Correspondent
Micromed
3508 Market St.
Philadelphia,  PA  19104
Correspondent Contact SALEEM HASAN
Regulation Number870.2340
Classification Product Code
DPS  
Date Received10/22/1991
Decision Date 12/05/1991
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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