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FDA 510(k) Application Details - K083185
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K083185
Device Name
Thermometer, Electronic, Clinical
Applicant
CADI SCIENTIFIC PTE.LTD
S65 W35739 PIPER ROAD
EAGLE, WI 53119 US
Other 510(k) Applications for this Company
Contact
STEPHEN H GORSKI
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
10/29/2008
Decision Date
03/11/2009
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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