Cleared Traditional

KAVO ERGOCOM/ERGOCAM

K050744 · Kavo America Corporation · Radiology

Apr 2005

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K050744 is an FDA 510(k) clearance for the KAVO ERGOCOM/ERGOCAM, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Kavo America Corporation (Deer Field, US). The FDA issued a Cleared decision on April 21, 2005, 30 days after receiving the submission on March 22, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K050744 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2005
Decision Date	April 21, 2005
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF