FDA 510(k) Application Details - K200695

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K200695
Device Name	Ventilatory Effort Recorder
Applicant	Zephyr Sleep Technologies 102, 701 64 Ave SE Calgary T2H-2C3 CA Other 510(k) Applications for this Company
Contact	Sabina Bruehlmann 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	03/17/2020
Decision Date	08/24/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review