FDA 510(k) Application Details - K233486

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K233486
Device Name	Ventilator, Continuous, Facility Use
Applicant	Zoll Medical Corporation 269 Mill Road Chelmsford, MA 01824 US Other 510(k) Applications for this Company
Contact	Jeffrey Churchill 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	10/27/2023
Decision Date	12/13/2024
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