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FDA 510(k) Application Details - K981337
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K981337
Device Name
Thermometer, Electronic, Clinical
Applicant
MESURE TECHNOLOGY
26792 VIA ALCALA
MISSION VIEJO, CA 92691-3432 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
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More FDA Info for this Product Code
Date Received
04/13/1998
Decision Date
09/30/1998
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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