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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, Fluoroscopic, Image-Intensified
510(k) Number K901153
Device Name SONY VO-5800H VIDEOCASSETTE RECORDER
Applicant
Sony Medical Electronics Co.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Applicant Contact A SINCLAIR
Correspondent
Sony Medical Electronics Co.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Correspondent Contact A SINCLAIR
Regulation Number892.1650
Classification Product Code
JAA  
Date Received03/13/1990
Decision Date 04/19/1990
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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