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FDA 510(k)

Nexy

K-Number: K180306 · 2018-06-08

ApplicantNext Sight Srl
Decision Date2018-06-08
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Nexy is the device name listed in this FDA 510(k) record. The listed applicant is Next Sight Srl. It received FDA 510(k) clearance on 2018-06-08 under 510(k) number K180306. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nexy?

Nexy is a medical device that received FDA 510(k) clearance on 2018-06-08. The listed applicant is Next Sight Srl. The 510(k) number is K180306.

When did Nexy receive FDA 510(k) clearance?

Nexy received FDA 510(k) clearance on 2018-06-08, under 510(k) number K180306.

Who is the listed applicant for Nexy?

The FDA 510(k) record lists Next Sight Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nexy?

The FDA product code for Nexy is HKI.

Related Devices (Code: HKI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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