FDA 510(k) Application Details - K211346

Device Classification Name	More FDA Info for this Device
510(K) Number	K211346
Device Name	BLUE 400
Applicant	Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 Jena 07745 DE Other 510(k) Applications for this Company
Contact	Hans-Joachim Miesner Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/2021
Decision Date	07/22/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review