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FDA 510(k) Application Details - K964851
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K964851
Device Name
Thermometer, Electronic, Clinical
Applicant
ENTRACARE CORP.
14400 COLLEGE BLVD., SUITE 101
LENEXA, KS 66215 US
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Contact
AL BOEDEKER
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
12/03/1996
Decision Date
02/03/1997
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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