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FDA 510(k)

NuVasive® VuePoint® II OCT System

K-Number: K180198 · 2018-03-15

Decision Date2018-03-15
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NuVasive® VuePoint® II OCT System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2018-03-15 under approval number K180198. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuVasive® VuePoint® II OCT System?

NuVasive® VuePoint® II OCT System is a medical device that received FDA 510(k) clearance on 2018-03-15. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K180198.

When was NuVasive® VuePoint® II OCT System approved by the FDA?

NuVasive® VuePoint® II OCT System received FDA 510(k) clearance on 2018-03-15, under approval number K180198.

What company makes NuVasive® VuePoint® II OCT System?

NuVasive® VuePoint® II OCT System is manufactured by Nu Vasive, Incorporated.

What is the FDA product code for NuVasive® VuePoint® II OCT System?

The FDA product code for NuVasive® VuePoint® II OCT System is NKG.

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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.