BRAXX Esophageal Brachytherapy Applicator— 510(k) K183332

Name: FDA 510(k) clearance K183332
Creator: U.S. Food and Drug Administration
Published: 2019-04-16

Substantially Equivalent

Braxx Biotech Co., Ltd.

FDA 510(k) clearance K183332 for BRAXX Esophageal Brachytherapy Applicator, Substantially Equivalent on 2019-04-16. 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: 2018-12-03
Decision date: 2019-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

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