510(k) K001841

35/CD CINECONVERTER by Tagarno A/S — Product Code LMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2000
Date Received
June 19, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Digitizer, Image, Radiological
Device Class
Class II
Regulation Number
892.2030
Review Panel
RA
Submission Type