FDA 510(k) Application Details - K120004

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K120004
Device Name	Thermometer, Electronic, Clinical
Applicant	CHINA SHENYANG MED-LAND IMP/EXP CORP., LTD. 19 SEDGEMEADOW RD WAYLAND, MA 01778 US Other 510(k) Applications for this Company
Contact	ANN D MCGONIGLE 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	01/03/2012
Decision Date	08/23/2012
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