FDA 510(k)

智能止痛器，型號 LT5019

K 號：K162479 · 2017-02-08

申請人Shenzhen Dongdixin Technology Co., Ltd.

決定日期2017-02-08

產品代碼NUH

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Smart Pain Reliever, Model LT5019 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 2017-02-08 under 510(k) number K162479. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Smart Pain Reliever, Model LT5019?

Smart Pain Reliever, Model LT5019 is a medical device that received FDA 510(k) clearance on 2017-02-08. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K162479.

When did Smart Pain Reliever, Model LT5019 receive FDA 510(k) clearance?

Smart Pain Reliever, Model LT5019 received FDA 510(k) clearance on 2017-02-08, under 510(k) number K162479.

Who is the listed applicant for Smart Pain Reliever, Model LT5019?

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 Smart Pain Reliever, Model LT5019?

The FDA product code for Smart Pain Reliever, Model LT5019 is NUH.

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