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FDA 510(k) Application Details - K012217
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K012217
Device Name
Thermometer, Electronic, Clinical
Applicant
MEDISIM LTD.
117 AHUZAH ST.
RA'ANANNA IL
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Contact
SHOSHANA FRIEDMAN
Other 510(k) Applications for this Contact
Regulation Number
880.2910
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Classification Product Code
FLL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/16/2001
Decision Date
08/01/2001
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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