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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, St Segment With Alarm
510(k) Number K960934
Device Name HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24
Applicant
Hewlett-Packard Co.
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact RAY STELTING
Correspondent
Hewlett-Packard Co.
3000 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact RAY STELTING
Regulation Number870.1025
Classification Product Code
MLD  
Date Received03/08/1996
Decision Date 06/14/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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