FDA 510(k) Application Details - K190732

Device Classification Name	Tomography, Optical Coherence   More FDA Info for this Device
510(K) Number	K190732
Device Name	Tomography, Optical Coherence
Applicant	Optos Plc Queensferry House, Carnegie Campus, Enterprise Way Dunfermline ky11 8gr GB Other 510(k) Applications for this Company
Contact	Rachel Reay Other 510(k) Applications for this Contact
Regulation Number	886.1570   More FDA Info for this Regulation Number
Classification Product Code	OBO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/21/2019
Decision Date	07/31/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review