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FDA 510(k) Application Details - K111637
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K111637
Device Name
Thermometer, Electronic, Clinical
Applicant
RADIANT INNOVATION, INC.
1F,NO. 3,INDUSTRIAL E. 9TH RD
SCIENCE-BASED INDUSTRIAL PARK
HSINCHU 30075 TW
Other 510(k) Applications for this Company
Contact
LYNN CHEN
Other 510(k) Applications for this Contact
Regulation Number
880.2910
More FDA Info for this Regulation Number
Classification Product Code
FLL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/13/2011
Decision Date
12/06/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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