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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K873452
Device Name MODIFIED MODEL SSD-650 SYSTEM
Applicant
Ge Medical Systems Information Technologies
61 Barnes Park Rd. N.
Wallingford,  CT  06492
Applicant Contact J. P LENZEN
Correspondent
Ge Medical Systems Information Technologies
61 Barnes Park Rd. N.
Wallingford,  CT  06492
Correspondent Contact J. P LENZEN
Regulation Number892.1560
Classification Product Code
IYO  
Date Received08/27/1987
Decision Date 07/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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