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FDA 510(k) Application Details - K100495
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K100495
Device Name
Thermometer, Electronic, Clinical
Applicant
PHILIPS ELECTRONICS UK LIMITED
LOWER ROAD
GLEMSFORD, SUFFOLK CO10 7QS GB
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Contact
MIRIAM SHARIF-MURRAY
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
02/19/2010
Decision Date
06/22/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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