FDA 510(k)

Surgical Drive System (Model: ES70, ES90, E8)

Número K: K240340 · 2024-07-18

RequerenteGuangdong Jinme Medical Technology Co., Ltd.

Data da decisão2024-07-18

Código do produtoDZI

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surgical Drive System (Model: ES70, ES90, E8) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Jinme Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-07-18 under 510(k) number K240340. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Surgical Drive System (Model: ES70, ES90, E8)?

Surgical Drive System (Model: ES70, ES90, E8) is a medical device that received FDA 510(k) clearance on 2024-07-18. The listed applicant is Guangdong Jinme Medical Technology Co., Ltd.. The 510(k) number is K240340.

When did Surgical Drive System (Model: ES70, ES90, E8) receive FDA 510(k) clearance?

Surgical Drive System (Model: ES70, ES90, E8) received FDA 510(k) clearance on 2024-07-18, under 510(k) number K240340.

Who is the listed applicant for Surgical Drive System (Model: ES70, ES90, E8)?

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

What is the FDA product code for Surgical Drive System (Model: ES70, ES90, E8)?

The FDA product code for Surgical Drive System (Model: ES70, ES90, E8) is DZI.

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Dispositivos Relacionados (Código: DZI)

K253655Angled Screwdriver MED (M-SD090)W&H Dentalwerk Bürmoos GmbH K253776Implantmed Plus II & Piezomed Plus II ModuleW&H Dentalwerk Buermoos GmbH K254163VarioSurg 4Nakanishi, Inc.K242432MT-BoneMectron S.P.A.K231087Guided Surgery KitImplant Direct Sybron Manufacturing, LLC K192561TRAUS SUS20Saeshin Precision Co., Ltd.

Fonte oficial

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