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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K921014
Device Name MODEL M2350A AND M2360A WAVEVUE CENTRAL MONITOR
Applicant
Hewlett-Packard Co.
175 Waltham St.
P.O.Box 9030
Waltham,  MA  02254
Applicant Contact DAVID OSBORN
Correspondent
Hewlett-Packard Co.
175 Waltham St.
P.O.Box 9030
Waltham,  MA  02254
Correspondent Contact DAVID OSBORN
Regulation Number870.1025
Classification Product Code
MHX  
Date Received03/03/1992
Decision Date 10/01/1992
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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