FDA 510(k) Application Details - K221816

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K221816
Device Name	Ventilatory Effort Recorder
Applicant	Wesper Inc. 234 5th Ave New York, NY 10001 US Other 510(k) Applications for this Company
Contact	Amir Reuveny 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	06/22/2022
Decision Date	03/09/2023
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