FDA 510(k)

High Pressure Tubing

Número K: K232388 · 2023-11-21

RequerenteNingbo Dizegens Medical Science Co.,Ltd

Data da decisão2023-11-21

Código do produtoDXT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

High Pressure Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Dizegens Medical Science Co.,Ltd. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K232388. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the High Pressure Tubing?

High Pressure Tubing is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Ningbo Dizegens Medical Science Co.,Ltd. The 510(k) number is K232388.

When did High Pressure Tubing receive FDA 510(k) clearance?

High Pressure Tubing received FDA 510(k) clearance on 2023-11-21, under 510(k) number K232388.

Who is the listed applicant for High Pressure Tubing?

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

What is the FDA product code for High Pressure Tubing?

The FDA product code for High Pressure Tubing is DXT.

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Fonte oficial

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