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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Imager, Ultrasonic Obstetric-Gynecologic
510(k) Number K900271
Device Name MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK
Applicant
DIGISONICS, INC.
2401 PORTSMOUTH
HOUSTON,  TX  77098
Applicant Contact DONNA J KANON
Correspondent
DIGISONICS, INC.
2401 PORTSMOUTH
HOUSTON,  TX  77098
Correspondent Contact DONNA J KANON
Regulation Number884.2225
Classification Product Code
HEM  
Date Received01/19/1990
Decision Date 04/19/1990
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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