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FDA 510(k)

BioTraceIO Precision (2.0)

N.º K: K243084 · 2024-12-27

SolicitanteTechsomed Medical Technologies , Ltd.
Fecha de decisión2024-12-27
Código de productoQZL
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Fuente oficial

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