FDA 510(k) Application Details - K190022

Device Classification Name	Filter, Bacterial, Breathing-Circuit   More FDA Info for this Device
510(K) Number	K190022
Device Name	Filter, Bacterial, Breathing-Circuit
Applicant	MD Diagnostics Limited 15 Hollingworth Court, Turkey Mill Maidstone ME14 5pp GB Other 510(k) Applications for this Company
Contact	Glen Hillsley Other 510(k) Applications for this Contact
Regulation Number	868.5260   More FDA Info for this Regulation Number
Classification Product Code	CAH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/04/2019
Decision Date	09/25/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review