FDA 510(k)

BEACON Caresystem Model 00002144

N.º K: K192584 · 2019-12-18

Fecha de decisión2019-12-18

Código de productoBZK

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

BEACON Caresystem Model 00002144 is the device name listed in this FDA 510(k) record. The listed applicant is Mermaid Care A/S. It received FDA 510(k) clearance on 2019-12-18 under 510(k) number K192584. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BEACON Caresystem Model 00002144?

BEACON Caresystem Model 00002144 is a medical device that received FDA 510(k) clearance on 2019-12-18. The listed applicant is Mermaid Care A/S. The 510(k) number is K192584.

When did BEACON Caresystem Model 00002144 receive FDA 510(k) clearance?

BEACON Caresystem Model 00002144 received FDA 510(k) clearance on 2019-12-18, under 510(k) number K192584.

Who is the listed applicant for BEACON Caresystem Model 00002144?

The FDA 510(k) record lists Mermaid Care A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BEACON Caresystem Model 00002144?

The FDA product code for BEACON Caresystem Model 00002144 is BZK.

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Fuente oficial

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