FDA 510(k) Application Details - K242354

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K242354
Device Name	Nebulizer (Direct Patient Interface)
Applicant	Enchant Tek Co. Ltd. No. 210 Xiangzhong Rd. Dongshan Township Yilan County 26950 TW Other 510(k) Applications for this Company
Contact	Ling Leonard Other 510(k) Applications for this Contact
Regulation Number	868.5630   More FDA Info for this Regulation Number
Classification Product Code	CAF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2024
Decision Date	04/29/2025
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