BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)— 510(k) K243045

Name: FDA 510(k) clearance K243045
Creator: U.S. Food and Drug Administration
Published: 2024-11-19

Substantially Equivalent

Braxx Biotech Co., Ltd.

FDA 510(k) clearance K243045 for BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002), Substantially Equivalent on 2024-11-19. Applicant: Braxx Biotech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Braxx Biotech Co., Ltd.
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2024-09-27
Decision date: 2024-11-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.