FDA 510(k) Application Details - K233564

Device Classification Name	More FDA Info for this Device
510(K) Number	K233564
Device Name	FLUOBEAM« LX Imaging System (FB-LX); FLUOBEAM« LX Red Imaging System (FB-LXR)
Applicant	Fluoptics Sas (a Getinge Group Company) 44 rue des berges Grenoble 38000 FR Other 510(k) Applications for this Company
Contact	Marion Boudet Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/2023
Decision Date	12/15/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review