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FDA 510(k) Application Details - K090031
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K090031
Device Name
Thermometer, Electronic, Clinical
Applicant
ACTHERM, INC.
6F, NO.18 JHANYE 2ND RD.,
HSINCHU SCIENCE PARK
HSINCHU 30078 TW
Other 510(k) Applications for this Company
Contact
RICHARD HSIEH
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
01/05/2009
Decision Date
04/16/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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