FDA 510(k) Application Details - K120412

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K120412
Device Name	Thermometer, Electronic, Clinical
Applicant	ARIZANT HEALTHCARE INC. 10393 WEST 70TH ST. EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	DAVID WESTLIN 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	02/10/2012
Decision Date	05/30/2012
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