BEHIND EAR GENTLE TOUCH THERMOMETER


Device Classification Name

thermometer, electronic, clinical

510(k) Number K103839
Device Name BEHIND EAR GENTLE TOUCH THERMOMETER
Applicant
KAZ, INC.
250 turnpike rod
southborough, 
MA 
01772

Applicant Contact raj s kasbekar
Correspondent
KAZ, INC.
250 turnpike rod
southborough, 
MA 
01772

Correspodent Contact raj s kasbekar
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 12/30/2010
Decision Date 06/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Abbreviated
Reviewed by Third Party No

Combination Product

No