FDA 510(k)

EzRay Air 2 Wall (Model: VEX-S350W)

Número K: K223058 · 2022-10-26

Data da decisão2022-10-26

Código do produtoEHD

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

EzRay Air 2 Wall (Model: VEX-S350W) is the device name listed in this FDA 510(k) record. The listed applicant is VATECH Co., Ltd.. It received FDA 510(k) clearance on 2022-10-26 under 510(k) number K223058. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EzRay Air 2 Wall (Model: VEX-S350W)?

EzRay Air 2 Wall (Model: VEX-S350W) is a medical device that received FDA 510(k) clearance on 2022-10-26. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K223058.

When did EzRay Air 2 Wall (Model: VEX-S350W) receive FDA 510(k) clearance?

EzRay Air 2 Wall (Model: VEX-S350W) received FDA 510(k) clearance on 2022-10-26, under 510(k) number K223058.

Who is the listed applicant for EzRay Air 2 Wall (Model: VEX-S350W)?

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

What is the FDA product code for EzRay Air 2 Wall (Model: VEX-S350W)?

The FDA product code for EzRay Air 2 Wall (Model: VEX-S350W) is EHD.

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Outros registros que listam VATECH Co., Ltd. como candidato(a)

K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)K243088Green X 12 SE (PHT-40CHS)K243081Green X 21 (PHT-90CHO)K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)K231796Grreen X 12 (Model: PHT-75CHS)K213462EzRay M18 (Model: VMX-P400)

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Fonte oficial

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