510(k) K081088

MYRAY SKYVIEW by Cefla S.C. — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2008
Date Received
April 16, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type