510(k) K050744

KAVO ERGOCOM/ERGOCAM by Kavo America Corporation — Product Code LLZ

K050744 is an FDA 510(k) premarket notification submitted by Kavo America Corporation for the device "KAVO ERGOCOM/ERGOCAM". The FDA issued a decision of Substantially Equivalent on April 21, 2005. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Kavo America Corporation has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2005
Date Received
March 22, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type