FDA 510(k) Application Details - K162783

Device Classification Name	Tomography, Optical Coherence   More FDA Info for this Device
510(K) Number	K162783
Device Name	Tomography, Optical Coherence
Applicant	Bioptigen, Inc. 633 Davis Drive Morrisville, NC 27560 US Other 510(k) Applications for this Company
Contact	Ravi Kommineni 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	10/03/2016
Decision Date	12/09/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review