FDA 510(k) Application Details - K102718

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K102718
Device Name	Thermometer, Electronic, Clinical
Applicant	INTERNATIONAL REGULATORY CONSULTANTS, LLC (IRC) 16F-2(16A), SEC. 2 CHONG DE RD TAICHUNG 406 CN Other 510(k) Applications for this Company
Contact	JACOB CHANG 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	09/21/2010
Decision Date	12/13/2010
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