FDA 510(k)

Eco-x 系列產品（eco-x, eco-x-s）

K 號：K211159 · 2021-12-30

決定日期2021-12-30

產品代碼OAS

諮詢委員會RA

決定相當於

器材摘要

eco-x Series (eco-x, eco-x-s) is the device name listed in this FDA 510(k) record. The listed applicant is Hdx Will Corp.. It received FDA 510(k) clearance on 2021-12-30 under 510(k) number K211159. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the eco-x Series (eco-x, eco-x-s)?

eco-x Series (eco-x, eco-x-s) is a medical device that received FDA 510(k) clearance on 2021-12-30. The listed applicant is Hdx Will Corp.. The 510(k) number is K211159.

When did eco-x Series (eco-x, eco-x-s) receive FDA 510(k) clearance?

eco-x Series (eco-x, eco-x-s) received FDA 510(k) clearance on 2021-12-30, under 510(k) number K211159.

Who is the listed applicant for eco-x Series (eco-x, eco-x-s)?

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

What is the FDA product code for eco-x Series (eco-x, eco-x-s)?

The FDA product code for eco-x Series (eco-x, eco-x-s) is OAS.

其他以 Hdx Will Corp. 為申請人之記錄

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相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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