FDA 510(k)

Elexir

K 號：K211380 · 2021-07-30

決定日期2021-07-30

產品代碼PCC

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

Elexir is the device name listed in this FDA 510(k) record. The listed applicant is Nu Eyne Co., Ltd.. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K211380. The device is classified under product code PCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Elexir?

Elexir is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Nu Eyne Co., Ltd.. The 510(k) number is K211380.

When did Elexir receive FDA 510(k) clearance?

Elexir received FDA 510(k) clearance on 2021-07-30, under 510(k) number K211380.

Who is the listed applicant for Elexir?

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

What is the FDA product code for Elexir?

The FDA product code for Elexir is PCC.

其他以 Nu Eyne Co., Ltd. 為申請人之記錄

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。

K243289ADDNOX (BPSPM1)K242719ELEXIR 2.0 (ALLIVE3)K213629SMILE K192773ALLIVE

相關器械（代碼：PCC）

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。

K254216Enso 頭痛用藥品Hinge Health, Inc.K242719ELEXIR 2.0 (ALLIVE3)Nu Eyne Co., Ltd.K234029CEFALY 連接 - 非處方藥，CEFALY 連接 - 藥局處方Cefaly Technology K232749DOOPANGYbrain, Inc.K233751米維爾（YPS-301BD）Soterix Medical, Inc.K230782TENS設備-HeadaTerm 2（型號：YF-HT2）Wat Medical Technology, Inc.

官方來源

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