BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS


Device Classification Name

thermometer, electronic, clinical

510(k) Number K103800
Device Name BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS
Applicant
KAZ USA, INC (A SUBSIDIARY OF KAZ INC)
250 turnpike road
southborough, 
MA 
01772

Applicant Contact raj kasbekar
Correspondent
KAZ USA, INC (A SUBSIDIARY OF KAZ INC)
250 turnpike road
southborough, 
MA 
01772

Correspodent Contact raj kasbekar
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 12/28/2010
Decision Date 01/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No