FDA 510(k) Application Details - K200321

Device Classification Name	Cleaner, Air, Medical Recirculating   More FDA Info for this Device
510(K) Number	K200321
Device Name	Cleaner, Air, Medical Recirculating
Applicant	Novaerus US Inc 35 Melrose Place Stamford, CT 06902 US Other 510(k) Applications for this Company
Contact	Declan Kiely 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	02/10/2020
Decision Date	12/28/2020
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