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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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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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