FDA 510(k) Application Details - K183320

Device Classification Name	System, Imaging, Optical Coherence Tomography (Oct)   More FDA Info for this Device
510(K) Number	K183320
Device Name	System, Imaging, Optical Coherence Tomography (Oct)
Applicant	St. Jude Medical (now Abbott Medical) One St. Jude Medical Drive St. Paul, MN 55117 US Other 510(k) Applications for this Company
Contact	Steve Vitale 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	11/30/2018
Decision Date	04/02/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review