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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 K882609
Device Name MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM
Applicant
Waltham Div. Hewlett Packard
175 Wyman St.
Waltham,  MA  02254
Applicant Contact NICHOLAS POLY
Correspondent
Waltham Div. Hewlett Packard
175 Wyman St.
Waltham,  MA  02254
Correspondent Contact NICHOLAS POLY
Regulation Number870.2300
Classification Product Code
DRT  
Date Received06/27/1988
Decision Date 01/19/1989
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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