K-number	DEN230020
Device name	BioTraceIO Lite
Applicant	Techsomed Medical Technologies , Ltd.
Product code	QZL
Device class	Class II
Decision date	Dec 22, 2023
Decision	Not Substantially Equivalent
Regulation	892.2052

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Source

View the full FDA submission: accessdata.fda.gov

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BioTraceIO Lite

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