510(k) K781287

DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH by Siemens Corp. — Product Code EAG

K781287 is an FDA 510(k) premarket notification submitted by Siemens Corp. for the device "DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH". The FDA issued a decision of Substantially Equivalent on September 11, 1978. The device falls under product code EAG (Cephalometer), a Class II device regulated under 21 CFR 872.1830. Siemens Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1978
Date Received
July 26, 1978
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