FDA 510(k)

Well Lead All Silicone Foley Catheter with Temperature Sensor

Número K: K202134 · 2021-04-08

Data da decisão2021-04-08

Código do produtoEZL

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Well Lead All Silicone Foley Catheter with Temperature Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-04-08 under 510(k) number K202134. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Well Lead All Silicone Foley Catheter with Temperature Sensor?

Well Lead All Silicone Foley Catheter with Temperature Sensor is a medical device that received FDA 510(k) clearance on 2021-04-08. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K202134.

When did Well Lead All Silicone Foley Catheter with Temperature Sensor receive FDA 510(k) clearance?

Well Lead All Silicone Foley Catheter with Temperature Sensor received FDA 510(k) clearance on 2021-04-08, under 510(k) number K202134.

Who is the listed applicant for Well Lead All Silicone Foley Catheter with Temperature Sensor?

The FDA 510(k) record lists Well Lead Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Well Lead All Silicone Foley Catheter with Temperature Sensor?

The FDA product code for Well Lead All Silicone Foley Catheter with Temperature Sensor is EZL.

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Fonte oficial

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