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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 K844184
Device Name D300 PORT ULTRASOUND LIN SCAN W/3.5 & 5.0 MHZ PROB
Applicant
D.R.G.
P.O. Box 1178
Mountainside,  NJ  07092
Applicant Contact BUTKOY
Correspondent
D.R.G.
P.O. Box 1178
Mountainside,  NJ  07092
Correspondent Contact BUTKOY
Regulation Number892.1560
Classification Product Code
IYO  
Date Received10/26/1984
Decision Date 09/06/1985
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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