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FDA 510(k)

Talis EMR with Talis +ACG (Talis EMR with +ACG)

N.º K: K233133 · 2024-04-01

SolicitanteTalis Clinical, LLC
Fecha de decisión2024-04-01
Código de productoMWI
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Talis EMR with Talis +ACG (Talis EMR with +ACG) is the device name listed in this FDA 510(k) record. The listed applicant is Talis Clinical, LLC. It received FDA 510(k) clearance on 2024-04-01 under 510(k) number K233133. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Talis EMR with Talis +ACG (Talis EMR with +ACG)?

Talis EMR with Talis +ACG (Talis EMR with +ACG) is a medical device that received FDA 510(k) clearance on 2024-04-01. The listed applicant is Talis Clinical, LLC. The 510(k) number is K233133.

When did Talis EMR with Talis +ACG (Talis EMR with +ACG) receive FDA 510(k) clearance?

Talis EMR with Talis +ACG (Talis EMR with +ACG) received FDA 510(k) clearance on 2024-04-01, under 510(k) number K233133.

Who is the listed applicant for Talis EMR with Talis +ACG (Talis EMR with +ACG)?

The FDA 510(k) record lists Talis Clinical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Talis EMR with Talis +ACG (Talis EMR with +ACG)?

The FDA product code for Talis EMR with Talis +ACG (Talis EMR with +ACG) is MWI.

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Fuente oficial

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