FDA 510(k) Application Details - K233501

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K233501
Device Name	Ventilatory Effort Recorder
Applicant	Largan Medical Co., Ltd 2F., No. 14. 23rd., Taichung Industrial Park, Nantun Dist., Taichung 40805 TW Other 510(k) Applications for this Company
Contact	Shih-min Chen Other 510(k) Applications for this Contact
Regulation Number	868.2375   More FDA Info for this Regulation Number
Classification Product Code	MNR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2023
Decision Date	07/26/2024
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