510(k) K913886

SONY DVR-10 DIGITAL VIDEOCASSETTE RECORDER by Sony Medical Electronics Co. — Product Code JAA

K913886 is an FDA 510(k) premarket notification submitted by Sony Medical Electronics Co. for the device "SONY DVR-10 DIGITAL VIDEOCASSETTE RECORDER". The FDA issued a decision of Substantially Equivalent on January 24, 1992. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Sony Medical Electronics Co. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1992
Date Received
August 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type