FDA 510(k) Application Details - K160540

Device Classification Name	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer   More FDA Info for this Device
510(K) Number	K160540
Device Name	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Applicant	FLEXICARE MEDICAL LIMITED CYNON VALLEY BUSINESS PARK MOUNTAIN ASH CF45 4ER GB Other 510(k) Applications for this Company
Contact	JOEL BIDDLE Other 510(k) Applications for this Contact
Regulation Number	868.5270   More FDA Info for this Regulation Number
Classification Product Code	BZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/26/2016
Decision Date	06/23/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review