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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 K840623
Device Name OBSTETRICAL ULTRASOUND COMPUTER
Applicant
R & S SYSTEMS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
R & S SYSTEMS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.2225
Classification Product Code
HEM  
Date Received02/14/1984
Decision Date 05/11/1984
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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