FDA 510(k)

SaviSafe Safety Device

Número K: K230287 · 2023-11-21

RequerenteSuzhou Savicred Biotechnology Co., Ltd.

Data da decisão2023-11-21

Código do produtoMEG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

SaviSafe Safety Device is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Savicred Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K230287. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SaviSafe Safety Device?

SaviSafe Safety Device is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Suzhou Savicred Biotechnology Co., Ltd.. The 510(k) number is K230287.

When did SaviSafe Safety Device receive FDA 510(k) clearance?

SaviSafe Safety Device received FDA 510(k) clearance on 2023-11-21, under 510(k) number K230287.

Who is the listed applicant for SaviSafe Safety Device?

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

What is the FDA product code for SaviSafe Safety Device?

The FDA product code for SaviSafe Safety Device is MEG.

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