FDA 510(k) Application Details - K191095

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K191095
Device Name	Ventilatory Effort Recorder
Applicant	Neurovirtual USA, INC. 3303 W Commercial Blvd #100 Fort Lauderdale, FL 33309 US Other 510(k) Applications for this Company
Contact	Eduardo Faria 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	04/25/2019
Decision Date	01/16/2020
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