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FDA 510(k) Application Details - K033534
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K033534
Device Name
Thermometer, Electronic, Clinical
Applicant
MINI-MITTER CO., INC.
20300 EMPIRE AVE. BLDG. B-3
BEND, OR 97701 US
Other 510(k) Applications for this Company
Contact
JACK E MCKENZIE
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
11/10/2003
Decision Date
04/22/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Y
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