FDA 510(k)

GOLFF Sterile Anti-Fog Solution

Numéro K : K231822 · 2024-02-26

DemandeurBatrik Medical Manufacturing, Inc.

Date de décision2024-02-26

Code produitOCT

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

GOLFF Sterile Anti-Fog Solution is the device name listed in this FDA 510(k) record. The listed applicant is Batrik Medical Manufacturing, Inc.. It received FDA 510(k) clearance on 2024-02-26 under 510(k) number K231822. The device is classified under product code OCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the GOLFF Sterile Anti-Fog Solution?

GOLFF Sterile Anti-Fog Solution is a medical device that received FDA 510(k) clearance on 2024-02-26. The listed applicant is Batrik Medical Manufacturing, Inc.. The 510(k) number is K231822.

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

GOLFF Sterile Anti-Fog Solution received FDA 510(k) clearance on 2024-02-26, under 510(k) number K231822.

Who is the listed applicant for GOLFF Sterile Anti-Fog Solution?

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

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

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

Essais cliniques associés

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Dispositifs connexes (Code : OCT)

K251068KnoxFog Anti-fogging DeviceUv One Hygienics, Inc.K221293E-Brik Visualization AssistantJdi Surgical, Inc.K190864Konix Anti-Fog SolutionTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler K181887AMD Anti-Fog SolutionAdvanced Medical Design Co., Ltd.K163257VitreOx Anti-fog SolutionSio2 Nanotech, LLC K152948Medline Anti-Fog SolutionMedline Industries, Inc.

Source officielle

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