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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name echocardiograph
510(k) Number K871400
Device Name SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING
Original Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
61 barnes park rd., north
wallingford,  CT  06492
Original Contact joseph p lenzen
Regulation Number870.2330
Classification Product Code
DXK  
Date Received04/08/1987
Decision Date 07/24/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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