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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 K842261
Device Name OB ULTRASOUND LINEAR SCANNER 630
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.2225
Classification Product Code
HEM  
Date Received06/07/1984
Decision Date 09/19/1984
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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