FDA 510(k) Application Details - K240807

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K240807
Device Name	Ventilator, Continuous, Facility Use
Applicant	Ventis Medical, Inc. 515 Executive Drive Princeton, NJ 08540 US Other 510(k) Applications for this Company
Contact	Glenn Laub 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	03/25/2024
Decision Date	08/13/2024
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