FDA 510(k) Application Details - K201743

Device Classification Name	More FDA Info for this Device
510(K) Number	K201743
Device Name	ClarifEye R1.0, ClarifEye Needle
Applicant	Philips Medical Systems Nederlands B.V. Veenpluis 6 Best 5684PC NL Other 510(k) Applications for this Company
Contact	Owen Callaghan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2020
Decision Date	02/23/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review