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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 K913886
Device Name SONY DVR-10 DIGITAL VIDEOCASSETTE RECORDER
Applicant
Sony Medical Electronics Co.
3 Paragon Dr.,
Montvale,  NJ  07645
Applicant Contact LYNNE M BENNETT
Correspondent
Sony Medical Electronics Co.
3 Paragon Dr.,
Montvale,  NJ  07645
Correspondent Contact LYNNE M BENNETT
Regulation Number892.1650
Classification Product Code
JAA  
Date Received08/29/1991
Decision Date 01/24/1992
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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