FDA 510(k) Application Details - K110305

Device Classification Name	Thermometer, Clinical Color Change   More FDA Info for this Device
510(K) Number	K110305
Device Name	Thermometer, Clinical Color Change
Applicant	BRYMILL CRYOGENIC CYSTEMS BUILDING 2, 105 WINDERMERE AVE ELLINGTON, CT 06029 US Other 510(k) Applications for this Company
Contact	CLAUDIO RUSSO Other 510(k) Applications for this Contact
Regulation Number	880.2900   More FDA Info for this Regulation Number
Classification Product Code	FQZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/2011
Decision Date	01/13/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review