FDA 510(k) Application Details - K121195

Device Classification Name	System, Imaging, Optical Coherence Tomography (Oct)   More FDA Info for this Device
510(K) Number	K121195
Device Name	System, Imaging, Optical Coherence Tomography (Oct)
Applicant	NINEPOINT MEDICAL, INC 1171 BARROIHET AVENUE HILLSBOROUGH, CA 94010 US Other 510(k) Applications for this Company
Contact	CINDY DOMECUS 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	04/19/2012
Decision Date	07/25/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review