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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 K863494
Device Name NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20
Applicant
Advantage Medical Systems, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Applicant Contact ANTHONY CALDERONI
Correspondent
Advantage Medical Systems, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Correspondent Contact ANTHONY CALDERONI
Regulation Number870.2300
Classification Product Code
DRT  
Date Received09/09/1986
Decision Date 12/22/1986
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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