FDA 510(k) Application Details - K201082

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K201082
Device Name	Ventilator, Continuous, Facility Use
Applicant	Vyaire Medical Inc 26125 N. Riverwoods Blvd. Mettawa, IL 60045 US Other 510(k) Applications for this Company
Contact	Colleen Watson Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	CBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2020
Decision Date	11/10/2021
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