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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 K901033
Device Name MER MULTIPLANE RECTAL PROBE (MRP)
Applicant
Medical Equipment Resources
16303 Panoramic Way
San Leandro,  CA  94578
Applicant Contact GARY J ALLSEBROOK
Correspondent
Medical Equipment Resources
16303 Panoramic Way
San Leandro,  CA  94578
Correspondent Contact GARY J ALLSEBROOK
Regulation Number892.1560
Classification Product Code
IYO  
Date Received03/06/1990
Decision Date 08/22/1990
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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