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FDA 510(k)

Heartland Health Surgical Mask

N.º K: K212366 · 2022-02-19

SolicitanteHeartland Health Products
Fecha de decisión2022-02-19
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Heartland Health Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Heartland Health Products. It received FDA 510(k) clearance on 2022-02-19 under 510(k) number K212366. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Heartland Health Surgical Mask?

Heartland Health Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-02-19. The listed applicant is Heartland Health Products. The 510(k) number is K212366.

When did Heartland Health Surgical Mask receive FDA 510(k) clearance?

Heartland Health Surgical Mask received FDA 510(k) clearance on 2022-02-19, under 510(k) number K212366.

Who is the listed applicant for Heartland Health Surgical Mask?

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

What is the FDA product code for Heartland Health Surgical Mask?

The FDA product code for Heartland Health Surgical Mask is FXX.

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Dispositivos relacionados (Código: FXX)

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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