FDA 510(k) Application Details - K222579

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K222579
Device Name	Ventilatory Effort Recorder
Applicant	Belun Technology Company Limited Unit 218, 2/F, Core Building 2, No. 1 Science Park West Avenue, Hong Kong Science Park Sha Tin CN Other 510(k) Applications for this Company
Contact	Leung Lap Wai Lydia 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	08/25/2022
Decision Date	02/23/2023
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