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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K904447
Device Name SONY CINE VIDEO SYSTEM SME-3500
Applicant
Sony Medical Electronics Co.
Sony Dr.
Park Ridge,  NJ  07656
Applicant Contact LYNNE M BENNETT
Correspondent
Sony Medical Electronics Co.
Sony Dr.
Park Ridge,  NJ  07656
Correspondent Contact LYNNE M BENNETT
Regulation Number892.1600
Classification Product Code
IZI  
Date Received09/28/1990
Decision Date 10/17/1990
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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