FDA 510(k), K163475, iVue

510(K) Number: K163475
Device Name: iVue
Manufacturer: Optovue, Inc.
Device Classification Name: tomography, optical coherence
Regulation Number: 886.1570
Classification Product Code: OBO
Date Received: 12/12/2016
Decision Date: 06/09/2017
Regulation Medical Specialty: Ophthalmic

Total pages: 2548
Fully redacted pages: 2224
Content pages: 324