FDA 510(k) Application Details - K092129

Device Classification Name	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer   More FDA Info for this Device
510(K) Number	K092129
Device Name	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Applicant	INTERSURGICAL, INC. 417 ELECTRONICS PKWY. LIVERPOOL, NY 13088 US Other 510(k) Applications for this Company
Contact	MICHAEL ZALEWSKI 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	07/15/2009
Decision Date	05/18/2010
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	N
Expedited Review