FDA 510(k) Application Details - K153283

Device Classification Name	System, Imaging, Optical Coherence Tomography (Oct)   More FDA Info for this Device
510(K) Number	K153283
Device Name	System, Imaging, Optical Coherence Tomography (Oct)
Applicant	Michelson Diagnostics Ltd Ground Floor Eclipse House, Eclipse Park, Sittingbourne Road Maidstone me14 3en GB Other 510(k) Applications for this Company
Contact	Martin Johns 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	11/12/2015
Decision Date	08/11/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review