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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name thermometer, electronic, clinical
510(k) Number K112189
Device Name THERMO PAL INFRARED EAR THERMOMETER
Original Applicant
DIGIO2 INTERNATIONAL CO., LTD.
2904 n. boldt drive
flagstaff,  AZ  86001
Original Contact jennifer reich
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/29/2011
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
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