FDA 510(k) Application Details - K241135

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K241135
Device Name	Ventilator, Continuous, Facility Use
Applicant	CorVent Medical, Inc. 1805 NDSU Research Park Drive N Suite 118 Fargo, ND 58102 US Other 510(k) Applications for this Company
Contact	Richard Walsh 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	04/24/2024
Decision Date	11/13/2024
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