VISIOFOCUS


Device Classification Name

thermometer, electronic, clinical

510(k) Number K122412
Device Name VISIOFOCUS
Applicant
TECNIMED S.R.L.
110 e. granada blvd
suite 209
ormond beach, 
FL 
32176

Applicant Contact claude berthoin
Correspondent
TECNIMED S.R.L.
110 e. granada blvd
suite 209
ormond beach, 
FL 
32176

Correspodent Contact claude berthoin
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 08/08/2012
Decision Date 03/13/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No