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FDA 510(k), K163475, iVue
FDA 510(k), K163475, iVue
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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
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
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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