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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 K904353
Device Name CARDIOMATIC MODEL MSC-2001
Applicant
Medical Systems Corp.
One Plz. Rd.
Greenvale,  NY  11548
Applicant Contact MARDIN VARELA
Correspondent
Medical Systems Corp.
One Plz. Rd.
Greenvale,  NY  11548
Correspondent Contact MARDIN VARELA
Regulation Number870.2300
Classification Product Code
DRT  
Date Received09/24/1990
Decision Date 12/20/1990
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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