FDA 510(k)

Balloon Inflation System

Número K: K232842 · 2024-02-29

RequerenteNingbo Hicren Biotechnology Co., Ltd.

Data da decisão2024-02-29

Código do produtoNDN

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Balloon Inflation System is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Hicren Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-29 under 510(k) number K232842. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Balloon Inflation System?

Balloon Inflation System is a medical device that received FDA 510(k) clearance on 2024-02-29. The listed applicant is Ningbo Hicren Biotechnology Co., Ltd.. The 510(k) number is K232842.

When did Balloon Inflation System receive FDA 510(k) clearance?

Balloon Inflation System received FDA 510(k) clearance on 2024-02-29, under 510(k) number K232842.

Who is the listed applicant for Balloon Inflation System?

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

What is the FDA product code for Balloon Inflation System?

The FDA product code for Balloon Inflation System is NDN.

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