FDA 510(k) Application Details - K212003

Device Classification Name	Display, Cathode-Ray Tube, Medical   More FDA Info for this Device
510(K) Number	K212003
Device Name	Display, Cathode-Ray Tube, Medical
Applicant	LivaNova Deutschland GmbH Lindberghstr. 25 Munich 80939 DE Other 510(k) Applications for this Company
Contact	Florian Goetz Other 510(k) Applications for this Contact
Regulation Number	870.2450   More FDA Info for this Regulation Number
Classification Product Code	DXJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2021
Decision Date	11/10/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review