FDA 510(k)

HALO

N.º K: K211788 · 2021-07-08

Fecha de decisión2021-07-08

Código de productoQAS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

HALO is the device name listed in this FDA 510(k) record. The listed applicant is Nicolab B.V.. It received FDA 510(k) clearance on 2021-07-08 under 510(k) number K211788. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HALO?

HALO is a medical device that received FDA 510(k) clearance on 2021-07-08. The listed applicant is Nicolab B.V.. The 510(k) number is K211788.

When did HALO receive FDA 510(k) clearance?

HALO received FDA 510(k) clearance on 2021-07-08, under 510(k) number K211788.

Who is the listed applicant for HALO?

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

What is the FDA product code for HALO?

The FDA product code for HALO is QAS.

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Fuente oficial

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