FDA 510(k)

Halo AF Detection System

Número K: K201208 · 2020-09-23

RequerenteLivmor

Data da decisão2020-09-23

Código do produtoDXH

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Halo AF Detection System is the device name listed in this FDA 510(k) record. The listed applicant is Livmor. It received FDA 510(k) clearance on 2020-09-23 under 510(k) number K201208. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Halo AF Detection System?

Halo AF Detection System is a medical device that received FDA 510(k) clearance on 2020-09-23. The listed applicant is Livmor. The 510(k) number is K201208.

When did Halo AF Detection System receive FDA 510(k) clearance?

Halo AF Detection System received FDA 510(k) clearance on 2020-09-23, under 510(k) number K201208.

Who is the listed applicant for Halo AF Detection System?

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

What is the FDA product code for Halo AF Detection System?

The FDA product code for Halo AF Detection System is DXH. This falls under the Hematology category.

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