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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 Doppler, Ultrasonic
510(k) Number K885211
Device Name RF-100 MONITOR, RF-P-2.5, RF-P-5, RF-P-7.5 PROBES
Applicant
Rf Design Assoc., Inc.
1224 Monterey Cir.
Plano,  TX  75075
Applicant Contact KENNETH GOLDSTEIN
Correspondent
Rf Design Assoc., Inc.
1224 Monterey Cir.
Plano,  TX  75075
Correspondent Contact KENNETH GOLDSTEIN
Regulation Number892.1550
Classification Product Code
IYN  
Date Received12/14/1988
Decision Date 06/13/1989
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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