FDA 510(k)

Mytens 模型：BW-TSX

K 號：K171026 · 2017-11-01

決定日期2017-11-01

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

Mytens Model: BW-TSX is the device name listed in this FDA 510(k) record. The listed applicant is Bewell Connect Corp.. It received FDA 510(k) clearance on 2017-11-01 under 510(k) number K171026. 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 Mytens Model: BW-TSX?

Mytens Model: BW-TSX is a medical device that received FDA 510(k) clearance on 2017-11-01. The listed applicant is Bewell Connect Corp.. The 510(k) number is K171026.

When did Mytens Model: BW-TSX receive FDA 510(k) clearance?

Mytens Model: BW-TSX received FDA 510(k) clearance on 2017-11-01, under 510(k) number K171026.

Who is the listed applicant for Mytens Model: BW-TSX?

The FDA 510(k) record lists Bewell Connect Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mytens Model: BW-TSX?

The FDA product code for Mytens Model: BW-TSX is NUH.

相關器械（代碼：NUH）

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器材摘要

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相關器械（代碼：NUH）

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