FDA 510(k) Application Details - K240215

Device Classification Name	More FDA Info for this Device
510(K) Number	K240215
Device Name	BLUE 400; BLUE 400 S
Applicant	Carl Zeiss Meditec AG Rudolf-Eber-Strasse 11 Oberkochen 73447 DE Other 510(k) Applications for this Company
Contact	Seitz Anke 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	01/26/2024
Decision Date	06/28/2024
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