BioTraceIO Precision (2.0)
K-Number: K243084 · 2024-12-27
Decision Date2024-12-27
Product CodeQZL
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
BioTraceIO Precision (2.0) is a medical device manufactured by Techsomed Medical Technologies , Ltd.. It received FDA 510(k) clearance on 2024-12-27 under approval number K243084. The device is classified under product code QZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BioTraceIO Precision (2.0)?
BioTraceIO Precision (2.0) is a medical device that received FDA 510(k) clearance on 2024-12-27. It is manufactured by Techsomed Medical Technologies , Ltd.. The 510(k) number is K243084.
When was BioTraceIO Precision (2.0) approved by the FDA?
BioTraceIO Precision (2.0) received FDA 510(k) clearance on 2024-12-27, under approval number K243084.
What company makes BioTraceIO Precision (2.0)?
BioTraceIO Precision (2.0) is manufactured by Techsomed Medical Technologies , Ltd..
What is the FDA product code for BioTraceIO Precision (2.0)?
The FDA product code for BioTraceIO Precision (2.0) is QZL.
Other Devices by Techsomed Medical Technologies , Ltd.
Related Devices (Code: QZL)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.