FDA 510(k)

“BRAXX” 식도 브라키터라피 애플리케이터

K-번호: K183332 · 2019-04-16

결정일2019-04-16

제품 코드JAQ

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

“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.

자주 묻는 질문

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.

Braxx Biotech Co., Ltd.를 신청인으로 등재한 기타 기록

K243045“BRAXX” 식도 브라키터라피 애플리케이터 (모델: BKMI2001, BKMI2002)

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