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FDA 510(k)

Konix Anti-Fog Solution

K-Number: K190864 · 2020-08-27

ApplicantTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler
Decision Date2020-08-27
Product CodeOCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Konix Anti-Fog Solution is the device name listed in this FDA 510(k) record. The listed applicant is Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler. It received FDA 510(k) clearance on 2020-08-27 under 510(k) number K190864. The device is classified under product code OCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Konix Anti-Fog Solution?

Konix Anti-Fog Solution is a medical device that received FDA 510(k) clearance on 2020-08-27. The listed applicant is Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler. The 510(k) number is K190864.

When did Konix Anti-Fog Solution receive FDA 510(k) clearance?

Konix Anti-Fog Solution received FDA 510(k) clearance on 2020-08-27, under 510(k) number K190864.

Who is the listed applicant for Konix Anti-Fog Solution?

The FDA 510(k) record lists Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Konix Anti-Fog Solution?

The FDA product code for Konix Anti-Fog Solution is OCT.

Related Devices (Code: OCT)

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.

K251068KnoxFog Anti-fogging DeviceUv One Hygienics, Inc.K231822GOLFF Sterile Anti-Fog SolutionBatrik Medical Manufacturing, Inc.K221293E-Brik Visualization AssistantJdi Surgical, Inc.K181887AMD Anti-Fog SolutionAdvanced Medical Design Co., Ltd.K163257VitreOx Anti-fog SolutionSio2 Nanotech, LLCK152948Medline Anti-Fog SolutionMedline Industries, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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