FDA 510(k)

Promisemed Safety Huber Needle

Número K: K230715 · 2023-06-08

RequerentePromisemed Hangzhou Meditech Co., Ltd.

Data da decisão2023-06-08

Código do produtoPTI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Promisemed Safety Huber Needle is the device name listed in this FDA 510(k) record. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2023-06-08 under 510(k) number K230715. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Promisemed Safety Huber Needle?

Promisemed Safety Huber Needle is a medical device that received FDA 510(k) clearance on 2023-06-08. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K230715.

When did Promisemed Safety Huber Needle receive FDA 510(k) clearance?

Promisemed Safety Huber Needle received FDA 510(k) clearance on 2023-06-08, under 510(k) number K230715.

Who is the listed applicant for Promisemed Safety Huber Needle?

The FDA 510(k) record lists Promisemed Hangzhou Meditech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Promisemed Safety Huber Needle?

The FDA product code for Promisemed Safety Huber Needle is PTI.

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Fonte oficial

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