510(k) K944162

DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM by Teledyne Water Pik — Product Code EAG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1994
Date Received
August 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cephalometer
Device Class
Class II
Regulation Number
872.1830
Review Panel
RA
Submission Type