FDA 510(k) Application Details - K242102

Device Classification Name	Cleaner, Air, Medical Recirculating   More FDA Info for this Device
510(K) Number	K242102
Device Name	Cleaner, Air, Medical Recirculating
Applicant	CerroZone LLC 13975 Riverport Place Drive, Suite 102 Maryland Heights, MO 64043 US Other 510(k) Applications for this Company
Contact	Marlon Robinson Other 510(k) Applications for this Contact
Regulation Number	880.5045   More FDA Info for this Regulation Number
Classification Product Code	FRF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2024
Decision Date	11/19/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review