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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 K942490
Device Name BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND
Applicant
Medical Soft, Inc.
4724 Leyden Way
Ellicott City,  MD  21042
Applicant Contact MAYUMI M HALL
Correspondent
Medical Soft, Inc.
4724 Leyden Way
Ellicott City,  MD  21042
Correspondent Contact MAYUMI M HALL
Regulation Number884.2225
Classification Product Code
HEM  
Date Received05/25/1994
Decision Date 02/15/1995
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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