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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 K810755
Device Name SQUINN VITATEK 500 SERIES PHYSIOL. MONI
Applicant
Vitatek
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Vitatek
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2300
Classification Product Code
DRT  
Date Received03/20/1981
Decision Date 04/03/1981
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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