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FDA 510(k) Application Details - K113141
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K113141
Device Name
Thermometer, Electronic, Clinical
Applicant
MICROLIFE INTELLECTUAL PROPERTY GMBH
55 NORTHERN BOULEVARD
SUITE 200
GREAT NECK, NY 10021 US
Other 510(k) Applications for this Company
Contact
SUSAN D GOLDSTEIN-FALK
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
10/24/2011
Decision Date
01/27/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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