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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 K864748
Device Name PM-8 HEART RATE MONITOR
Applicant
Pulse Time Products, Ltd.
City Gates 2-4 Southgate
Chichester, W. Sussex,  GB PO19 2DJ
Applicant Contact LEVESLEY
Correspondent
Pulse Time Products, Ltd.
City Gates 2-4 Southgate
Chichester, W. Sussex,  GB PO19 2DJ
Correspondent Contact LEVESLEY
Regulation Number870.2300
Classification Product Code
DRT  
Date Received12/05/1986
Decision Date 03/20/1987
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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