FDA 510(k)

BioTraceIO Precision (2.0)

K-Number: K243084 · 2024-12-27

ApplicantTechsomed Medical Technologies , Ltd.

Decision Date2024-12-27

Product CodeQZL

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BioTraceIO Precision (2.0) is the device name listed in this FDA 510(k) record. The listed applicant is Techsomed Medical Technologies , Ltd.. It received FDA 510(k) clearance on 2024-12-27 under 510(k) 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. The listed applicant is Techsomed Medical Technologies , Ltd.. The 510(k) number is K243084.

When did BioTraceIO Precision (2.0) receive FDA 510(k) clearance?

BioTraceIO Precision (2.0) received FDA 510(k) clearance on 2024-12-27, under 510(k) number K243084.

Who is the listed applicant for BioTraceIO Precision (2.0)?

The FDA 510(k) record lists Techsomed Medical Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioTraceIO Precision (2.0)?

The FDA product code for BioTraceIO Precision (2.0) is QZL.

Other records listing Techsomed Medical Technologies , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251931BioTraceIO Vision (V1.7)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.