FDA 510(k)

DeRoyal Temperature Monitoring Probe

N.º K: K200631 · 2020-12-23

Fecha de decisión2020-12-23

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

DeRoyal Temperature Monitoring Probe is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 2020-12-23 under 510(k) number K200631. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the DeRoyal Temperature Monitoring Probe?

DeRoyal Temperature Monitoring Probe is a medical device that received FDA 510(k) clearance on 2020-12-23. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K200631.

When did DeRoyal Temperature Monitoring Probe receive FDA 510(k) clearance?

DeRoyal Temperature Monitoring Probe received FDA 510(k) clearance on 2020-12-23, under 510(k) number K200631.

Who is the listed applicant for DeRoyal Temperature Monitoring Probe?

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

What is the FDA product code for DeRoyal Temperature Monitoring Probe?

The FDA product code for DeRoyal Temperature Monitoring Probe is FLL.

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Fuente oficial

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