FDA 510(k) Application Details - K243023

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K243023
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	Wellell Inc. No. 9, Min Sheng St., Tu-Cheng, New Tapei City, Taiwan New Taipei City 236044 TW Other 510(k) Applications for this Company
Contact	Chieh Yang Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	BZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2024
Decision Date	05/23/2025
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