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FDA 510(k), K181594, Spectralis HRA+OCT and variants with OCT Angiography Module
FDA 510(k), K181594, Spectralis HRA+OCT and variants with OCT Angiography Module
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510(K) Number: K181594
Device Name: Spectralis HRA+OCT and variants with OCT Angiography Module
Manufacturer: Christoph Schoess
Device Classification Name: Tomography, Optical Coherence
Regulation Number: OBO
Classification Product Code: 06/18/2018
Date Received: 09/13/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
Device Name: Spectralis HRA+OCT and variants with OCT Angiography Module
Manufacturer: Christoph Schoess
Device Classification Name: Tomography, Optical Coherence
Regulation Number: OBO
Classification Product Code: 06/18/2018
Date Received: 09/13/2018
Decision Date: Substantially Equivalent (SESE)
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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