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FDA 510(k) Application Details - K090361
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K090361
Device Name
Thermometer, Electronic, Clinical
Applicant
RYCOM ELECTRON TECHNOLOGY LIMITED
SUITE 8D, NO. 19, LANE 999
ZHONGSHAN NO. 2 ROAD (S)
SHANGHAI 200030 CN
Other 510(k) Applications for this Company
Contact
Diana Hong
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
02/12/2009
Decision Date
10/08/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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