Name: Predicase
Price: 199 USD

K-number	K243045
Device name	BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)
Applicant	Braxx Biotech Co., Ltd.
Product code	JAQ
Device class	Class II
Decision date	Nov 19, 2024
Decision	Substantially Equivalent
Regulation	892.5700

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Source

View the full FDA submission: accessdata.fda.gov

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BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)

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BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)