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FDA 510(k) Application Details - K101244
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K101244
Device Name
Thermometer, Electronic, Clinical
Applicant
TRUER MEDICAL INC.
1050 N BATAVIA STREET
ORANGE, CA 92867 US
Other 510(k) Applications for this Company
Contact
TIM TRUITT
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
05/04/2010
Decision Date
11/18/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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