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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 K760728
Device Name CONTINUOUS WAVE DOPPLER ULTRASOUND
Applicant
MEDSONICS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MEDSONICS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.2660
Classification Product Code
KNG  
Date Received09/27/1976
Decision Date 10/06/1976
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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