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FDA 510(k) Application Details - K051422
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K051422
Device Name
Thermometer, Electronic, Clinical
Applicant
MEDISIM LTD.
BEIT HAPA'AMON BOX 124
20 HATA'AS ST
KFAR SABA 44425 IL
Other 510(k) Applications for this Company
Contact
AHAVA STEIN
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
06/01/2005
Decision Date
09/01/2005
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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