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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 K002491
Device Name COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS
Applicant
Medison Co., Ltd.
16303 Panoramic Way
San Leandro,  CA  94578
Applicant Contact GARY J ALLSEBROOK
Correspondent
Tuv Product Service, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact CAROLE STAMP
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
IYO  
Date Received08/14/2000
Decision Date 08/25/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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