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FDA 510(k)

AMD Anti-Fog Solution

K-Number: K181887 · 2019-01-22

ApplicantAdvanced Medical Design Co., Ltd.
Decision Date2019-01-22
Product CodeOCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMD Anti-Fog Solution is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Design Co., Ltd.. It received FDA 510(k) clearance on 2019-01-22 under 510(k) number K181887. 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 AMD Anti-Fog Solution?

AMD Anti-Fog Solution is a medical device that received FDA 510(k) clearance on 2019-01-22. The listed applicant is Advanced Medical Design Co., Ltd.. The 510(k) number is K181887.

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

AMD Anti-Fog Solution received FDA 510(k) clearance on 2019-01-22, under 510(k) number K181887.

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

The FDA 510(k) record lists Advanced Medical Design Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Advanced Medical Design Co., Ltd. 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: 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.K190864Konix Anti-Fog SolutionTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal UrunlerK163257VitreOx Anti-fog SolutionSio2 Nanotech, LLCK152948Medline Anti-Fog SolutionMedline Industries, Inc.

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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