510(k) K052422

THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) by Flow X-Ray Corp. — Product Code EAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2005
Date Received
September 2, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Intraoral
Device Class
Class II
Regulation Number
872.1810
Review Panel
RA
Submission Type