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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Heart Sound, Fetal, Ultrasonic
510(k) Number K902190
Device Name FETAL PULSE DETECTOR MODEL DOP-1
Applicant
Advanced Medical Systems, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Applicant Contact ANTHONY CALDERONI
Correspondent
Advanced Medical Systems, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Correspondent Contact ANTHONY CALDERONI
Regulation Number884.2660
Classification Product Code
HEK  
Date Received05/16/1990
Decision Date 10/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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