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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 K873159
Device Name COMBISON(R) 310A REAL TIME ULTRASOUND SCANNER
Applicant
Cone Instruments, Inc.
5201 Naiman Pkwy.
Solon,  OH  44139
Applicant Contact JAY C CONE
Correspondent
Cone Instruments, Inc.
5201 Naiman Pkwy.
Solon,  OH  44139
Correspondent Contact JAY C CONE
Regulation Number892.1560
Classification Product Code
IYO  
Date Received08/11/1987
Decision Date 03/01/1988
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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