FDA 510(k) Application Details - K222214

Device Classification Name	Hood, Surgical   More FDA Info for this Device
510(K) Number	K222214
Device Name	Hood, Surgical
Applicant	THI Total Healthcare Innovation GmbH Gewerbestrasse 4 Feistritz im Rosental 9181 AT Other 510(k) Applications for this Company
Contact	Karl Hintermann Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FXY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2022
Decision Date	10/17/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review