FDA 510(k) Application Details - K214120

Device Classification Name	Sterilizer, Steam   More FDA Info for this Device
510(K) Number	K214120
Device Name	Sterilizer, Steam
Applicant	Maquet GmbH Kehler Strasse 31 Rastatt 76437 DE Other 510(k) Applications for this Company
Contact	Holger Ullrich Other 510(k) Applications for this Contact
Regulation Number	880.6880   More FDA Info for this Regulation Number
Classification Product Code	FLE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2021
Decision Date	05/18/2022
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