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FDA 510(k) Application Details - K011585
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K011585
Device Name
Thermometer, Electronic, Clinical
Applicant
MESURE TECHNOLOGY
P.O. BOX 2249
MISSION VIEJO, CA 92690 US
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Contact
PHIL ZULUETA
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
05/23/2001
Decision Date
06/13/2001
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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