FDA 510(k) Application Details - K231778

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K231778
Device Name	Ventilator, Continuous, Facility Use
Applicant	Nihon Kohden OrangeMed, LLC 1800 E. Wilshire Avenue Santa Ana, CA 92705 US Other 510(k) Applications for this Company
Contact	Sheryl Higgins 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	06/16/2023
Decision Date	03/01/2024
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