FDA 510(k) Application Details - K210384

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K210384
Device Name	Ventilator, Continuous, Facility Use
Applicant	Datex-Ohmeda, Inc. 3030 Ohmeda Drive, PO Box 7550 Madison, WI 53707-7550 US Other 510(k) Applications for this Company
Contact	Trishia Mercier 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	02/09/2021
Decision Date	11/04/2021
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