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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 K850290
Device Name ULTRASOUND GEL
Applicant
Litton Datamedix
Rte One
Sharon,  MA  02067
Applicant Contact DAVID O JONES
Correspondent
Litton Datamedix
Rte One
Sharon,  MA  02067
Correspondent Contact DAVID O JONES
Regulation Number892.1560
Classification Product Code
IYO  
Date Received01/24/1985
Decision Date 04/18/1985
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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