510(k) K965072

PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT by Kaycor Intl., Ltd. — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1997
Date Received
December 19, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type