FDA 510(k) Application Details - K220012

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K220012
Device Name	Ventilatory Effort Recorder
Applicant	Bresotec Inc 55 York Street Unit 200 Toronto M5J 1R7 CA Other 510(k) Applications for this Company
Contact	Esther Sur 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	01/04/2022
Decision Date	12/21/2022
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