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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 K850619
Device Name BEDSIDE PATIENT MONITOR W/MODULES
Applicant
Midwest Analog & Digital, Inc.
16308 W. Glendale Dr.
New Berlin,  WI  53151
Applicant Contact JAMES UTZERATH
Correspondent
Midwest Analog & Digital, Inc.
16308 W. Glendale Dr.
New Berlin,  WI  53151
Correspondent Contact JAMES UTZERATH
Regulation Number870.2300
Classification Product Code
DRT  
Date Received02/15/1985
Decision Date 06/06/1985
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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