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FDA 510(k) Application Details - K051233
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K051233
Device Name
Thermometer, Electronic, Clinical
Applicant
OMRON HEALTHCARE, INC.
3460 POINTE CREEK COURT #102
BONITA SPRINGS, FL 34134 US
Other 510(k) Applications for this Company
Contact
IWAO KOJIMA
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
05/13/2005
Decision Date
06/21/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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