FDA 510(k)

“BRAXX” Esophageal Brachytherapy Applicator

Número K: K183332 · 2019-04-16

Data da decisão2019-04-16

Código do produtoJAQ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

“BRAXX” Esophageal Brachytherapy Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Braxx Biotech Co., Ltd.. It received FDA 510(k) clearance on 2019-04-16 under 510(k) number K183332. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the “BRAXX” Esophageal Brachytherapy Applicator?

“BRAXX” Esophageal Brachytherapy Applicator is a medical device that received FDA 510(k) clearance on 2019-04-16. The listed applicant is Braxx Biotech Co., Ltd.. The 510(k) number is K183332.

When did “BRAXX” Esophageal Brachytherapy Applicator receive FDA 510(k) clearance?

“BRAXX” Esophageal Brachytherapy Applicator received FDA 510(k) clearance on 2019-04-16, under 510(k) number K183332.

Who is the listed applicant for “BRAXX” Esophageal Brachytherapy Applicator?

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

What is the FDA product code for “BRAXX” Esophageal Brachytherapy Applicator?

The FDA product code for “BRAXX” Esophageal Brachytherapy Applicator is JAQ.

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

K243045“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)

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Fonte oficial

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