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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 K850135
Device Name MEDWATCH 400 CARDIAC CENTRAL NURSES STATION
Applicant
Medwatch Systems, Inc.
P.O. Box 24705
Tempe,  AZ  85282
Applicant Contact JAMES G AMES
Correspondent
Medwatch Systems, Inc.
P.O. Box 24705
Tempe,  AZ  85282
Correspondent Contact JAMES G AMES
Regulation Number870.2300
Classification Product Code
DRT  
Date Received01/14/1985
Decision Date 05/16/1985
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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