FDA 510(k) Application Details - K190404

Device Classification Name	System, Imaging, Optical Coherence Tomography (Oct)   More FDA Info for this Device
510(K) Number	K190404
Device Name	System, Imaging, Optical Coherence Tomography (Oct)
Applicant	Perimeter Medical Imaging, Inc. 1 Yonge Street, Suite 201 Toronto M5E !E6 CA Other 510(k) Applications for this Company
Contact	Elizabeth Munro 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	02/19/2019
Decision Date	03/26/2019
Decision	SESE - SUBST EQUIV
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