510(k) K992385

ORTHOPANTOMOGRAPH OP100D by Instrumentarium Corp. — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1999
Date Received
July 16, 1999
Clearance Type
Traditional
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