FDA 510(k) Application Details - K241268

Device Classification Name	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer   More FDA Info for this Device
510(K) Number	K241268
Device Name	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Applicant	Exceleron Medical 5000 Township Parkway St. Paul, MN 55110 US Other 510(k) Applications for this Company
Contact	Keith Roberts 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	05/06/2024
Decision Date	08/02/2024
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