FDA 510(k) Application Details - K191117

Device Classification Name	System, Imaging, Optical Coherence Tomography (Oct)   More FDA Info for this Device
510(K) Number	K191117
Device Name	System, Imaging, Optical Coherence Tomography (Oct)
Applicant	NinePoint Medical, Inc 12 Oak Park Drive Bedford, MA 01730 US Other 510(k) Applications for this Company
Contact	Eman Namati Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	NQQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2019
Decision Date	07/19/2019
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review