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FDA 510(k)

SOLIX

K-Number: K222166 · 2022-11-09

ApplicantOptovue, Inc.
Decision Date2022-11-09
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SOLIX is the device name listed in this FDA 510(k) record. The listed applicant is Optovue, Inc.. It received FDA 510(k) clearance on 2022-11-09 under 510(k) number K222166. 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 SOLIX?

SOLIX is a medical device that received FDA 510(k) clearance on 2022-11-09. The listed applicant is Optovue, Inc.. The 510(k) number is K222166.

When did SOLIX receive FDA 510(k) clearance?

SOLIX received FDA 510(k) clearance on 2022-11-09, under 510(k) number K222166.

Who is the listed applicant for SOLIX?

The FDA 510(k) record lists Optovue, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLIX?

The FDA product code for SOLIX is OBO.

Other records listing Optovue, Inc. as applicant

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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Related Devices (Code: 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.

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