FDA 510(k) Application Details - K243244

Device Classification Name	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer   More FDA Info for this Device
510(K) Number	K243244
Device Name	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Applicant	GuangDong EDA Technology Co., Ltd No. 6, Ma'an 2nd Road, Chashan Town Guangdong Province 523393 CN Other 510(k) Applications for this Company
Contact	Kant Huang 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	10/11/2024
Decision Date	07/25/2025
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