FDA 510(k)

Foley Catheter with Temperature Sensor

Número K: K200757 · 2020-10-15

Data da decisão2020-10-15

Código do produtoEYC

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Foley Catheter with Temperature Sensor 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 2020-10-15 under 510(k) number K200757. The device is classified under product code EYC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Foley Catheter with Temperature Sensor?

Foley Catheter with Temperature Sensor is a medical device that received FDA 510(k) clearance on 2020-10-15. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K200757.

When did Foley Catheter with Temperature Sensor receive FDA 510(k) clearance?

Foley Catheter with Temperature Sensor received FDA 510(k) clearance on 2020-10-15, under 510(k) number K200757.

Who is the listed applicant for Foley Catheter with Temperature Sensor?

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 Foley Catheter with Temperature Sensor?

The FDA product code for Foley Catheter with Temperature Sensor is EYC.

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