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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, ultrasonic, fetal
510(k) Number K890139
Device Name TOITU DOPPLER FETUS DETECTOR, FD-400D
Applicant
TOITU OF AMERICA, INC.
983 OLD EAGLE SCHOOL RD.
WAYNE,  PA  19087
Applicant Contact A OGLETREE
Correspondent
TOITU OF AMERICA, INC.
983 OLD EAGLE SCHOOL RD.
WAYNE,  PA  19087
Correspondent Contact A OGLETREE
Regulation Number884.2660
Classification Product Code
KNG  
Date Received01/13/1989
Decision Date 03/29/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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