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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 K820825
Device Name CARDIAC MONITOR - RATE ALARM
Applicant
Hewlett-Packard Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Hewlett-Packard Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2300
Classification Product Code
DRT  
Date Received03/25/1982
Decision Date 04/15/1982
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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