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FDA 510(k), K222200, CIRRUS HD-OCT
FDA 510(k), K222200, CIRRUS HD-OCT
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510(K) Number: K222200
Device Name: CIRRUS HD-OCT
Manufacturer: Vidita Desai
Device Classification Name: Tomography, Optical Coherence
Regulation Number: OBO
Classification Product Code: KXA
Date Received: 07/25/2022
Decision Date: 04/13/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
Device Name: CIRRUS HD-OCT
Manufacturer: Vidita Desai
Device Classification Name: Tomography, Optical Coherence
Regulation Number: OBO
Classification Product Code: KXA
Date Received: 07/25/2022
Decision Date: 04/13/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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