FDA 510(k)

HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable

N.º K: K200319 · 2020-04-02

Fecha de decisión2020-04-02

Código de productoFMT

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable 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 2020-04-02 under 510(k) number K200319. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable?

HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable is a medical device that received FDA 510(k) clearance on 2020-04-02. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K200319.

When did HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable receive FDA 510(k) clearance?

HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable received FDA 510(k) clearance on 2020-04-02, under 510(k) number K200319.

Who is the listed applicant for HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable?

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 HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable?

The FDA product code for HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable is FMT.

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Fuente oficial

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