FDA 510(k)

TalWire

N.º K: K223791 · 2023-07-14

Fecha de decisión2023-07-14

Código de productoDQX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

TalWire is the device name listed in this FDA 510(k) record. The listed applicant is Embrace Medical , Ltd.. It received FDA 510(k) clearance on 2023-07-14 under 510(k) number K223791. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the TalWire?

TalWire is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Embrace Medical , Ltd.. The 510(k) number is K223791.

When did TalWire receive FDA 510(k) clearance?

TalWire received FDA 510(k) clearance on 2023-07-14, under 510(k) number K223791.

Who is the listed applicant for TalWire?

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

What is the FDA product code for TalWire?

The FDA product code for TalWire is DQX.

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Fuente oficial

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