FDA 510(k)

Neonatal Phototherapy System

N.º K: K200031 · 2020-10-05

SolicitanteAvalon Biomedical (Shenzhen) Limited

Fecha de decisión2020-10-05

Código de productoLBI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Neonatal Phototherapy System is the device name listed in this FDA 510(k) record. The listed applicant is Avalon Biomedical (Shenzhen) Limited. It received FDA 510(k) clearance on 2020-10-05 under 510(k) number K200031. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Neonatal Phototherapy System?

Neonatal Phototherapy System is a medical device that received FDA 510(k) clearance on 2020-10-05. The listed applicant is Avalon Biomedical (Shenzhen) Limited. The 510(k) number is K200031.

When did Neonatal Phototherapy System receive FDA 510(k) clearance?

Neonatal Phototherapy System received FDA 510(k) clearance on 2020-10-05, under 510(k) number K200031.

Who is the listed applicant for Neonatal Phototherapy System?

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

What is the FDA product code for Neonatal Phototherapy System?

The FDA product code for Neonatal Phototherapy System is LBI.

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Fuente oficial

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