FDA 510(k) Application Details - K212208

Device Classification Name	Display, Cathode-Ray Tube, Medical   More FDA Info for this Device
510(K) Number	K212208
Device Name	Display, Cathode-Ray Tube, Medical
Applicant	Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard Str. 2 Boeblingen 71034 DE Other 510(k) Applications for this Company
Contact	Johannes Schmid 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	07/15/2021
Decision Date	09/30/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review