Decision Date2018-01-19
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
DRI OCT Triton is a medical device manufactured by Topcon Corporation. It received FDA 510(k) clearance on 2018-01-19 under approval number K173119. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DRI OCT Triton?
DRI OCT Triton is a medical device that received FDA 510(k) clearance on 2018-01-19. It is manufactured by Topcon Corporation. The 510(k) number is K173119.
When was DRI OCT Triton approved by the FDA?
DRI OCT Triton received FDA 510(k) clearance on 2018-01-19, under approval number K173119.
What company makes DRI OCT Triton?
DRI OCT Triton is manufactured by Topcon Corporation.
What is the FDA product code for DRI OCT Triton?
The FDA product code for DRI OCT Triton is OBO.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.