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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 K771211
Device Name DOPPLER (UTD-5 & UTD-6)
Applicant
TERUMO AMERICA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TERUMO AMERICA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.2660
Classification Product Code
HEK  
Date Received07/05/1977
Decision Date 07/14/1977
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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