FDA 510(k) Application Details - K180001

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K180001
Device Name	Ventilatory Effort Recorder
Applicant	Embla Systems 1 Hines Road Suite 202 Kanata K2K 3C7 CA Other 510(k) Applications for this Company
Contact	Sanjay Mehta 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	01/02/2018
Decision Date	09/27/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review