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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 K811425
Device Name CARDIACMONITORS
Applicant
PULSE TIME PRODUCTS, LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
PULSE TIME PRODUCTS, LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.2300
Classification Product Code
DRT  
Date Received05/22/1981
Decision Date 09/16/1981
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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