BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)— 510(k) K243045
Substantially EquivalentBraxx 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..
Clearance details
- Applicant
- Braxx Biotech Co., Ltd.
- Product code
- Code JAQ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Taipei City, TW
Data sourced from openFDA. This site is unofficial and independent of the FDA.