FDA 510(k) Application Details - K210593

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K210593
Device Name	Ventilatory Effort Recorder
Applicant	Onera B.V. Torenallee 42-54 Eindhoven 5617BD NL Other 510(k) Applications for this Company
Contact	Ruben de Francisco Martin 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	03/01/2021
Decision Date	04/06/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review