FDA 510(k) Application Details - K213463

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K213463
Device Name	Ventilatory Effort Recorder
Applicant	Ectosense nv Bosbessenlaan 19 A Rotselaar 3110 BE Other 510(k) Applications for this Company
Contact	Bart Van Pee 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	10/27/2021
Decision Date	12/16/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review