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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 K991441
Device Name CADENCE DOPPLER ULTRASOUND SYSTEM
Applicant
Medasonics, Inc.
9712 S. Altamont Dr.
Sandy,  UT  84092
Applicant Contact WILLIAM E MCKAY
Correspondent
Medasonics, Inc.
9712 S. Altamont Dr.
Sandy,  UT  84092
Correspondent Contact WILLIAM E MCKAY
Regulation Number884.2660
Classification Product Code
KNG  
Date Received04/26/1999
Decision Date 12/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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