THERMO PAL INFRARED EAR THERMOMETER


Device Classification Name

thermometer, electronic, clinical

510(k) Number K112189
Device Name THERMO PAL INFRARED EAR THERMOMETER
Applicant
DIGIO2 INTERNATIONAL CO., LTD.
2904 n. boldt drive
flagstaff, 
AZ 
86001

Applicant Contact jennifer reich
Correspondent
DIGIO2 INTERNATIONAL CO., LTD.
2904 n. boldt drive
flagstaff, 
AZ 
86001

Correspodent Contact jennifer reich
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 07/29/2011
Decision Date 01/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No