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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 K842236
Device Name PATIENT MONITOR 78354A
Applicant
Hewlett-Packard Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Applicant Contact LENKE
Correspondent
Hewlett-Packard Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent Contact LENKE
Regulation Number870.2300
Classification Product Code
DRT  
Date Received06/05/1984
Decision Date 01/18/1985
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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