FDA 510(k)

Levator Elite（型號 LE9011）

K 號：K213043 · 2022-02-25

申請人Shenzhen Dongdixin Technology Co., Ltd.

決定日期2022-02-25

產品代碼IPF

諮詢委員會PM

決定相當於

器材摘要

Levator Elite (Model LE9011) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-02-25 under 510(k) number K213043. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Levator Elite (Model LE9011)?

Levator Elite (Model LE9011) is a medical device that received FDA 510(k) clearance on 2022-02-25. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K213043.

When did Levator Elite (Model LE9011) receive FDA 510(k) clearance?

Levator Elite (Model LE9011) received FDA 510(k) clearance on 2022-02-25, under 510(k) number K213043.

Who is the listed applicant for Levator Elite (Model LE9011)?

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

What is the FDA product code for Levator Elite (Model LE9011)?

The FDA product code for Levator Elite (Model LE9011) is IPF.

其他以 Shenzhen Dongdixin Technology Co., Ltd. 為申請人之記錄

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