FDA 510(k)

Elitone 裝置

K 號：K183585 · 2019-02-11

決定日期2019-02-11

產品代碼QAJ

諮詢委員會GU

決定相當於

器材摘要

Elitone Device is the device name listed in this FDA 510(k) record. The listed applicant is Elidah, Inc.. It received FDA 510(k) clearance on 2019-02-11 under 510(k) number K183585. The device is classified under product code QAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Elitone Device?

Elitone Device is a medical device that received FDA 510(k) clearance on 2019-02-11. The listed applicant is Elidah, Inc.. The 510(k) number is K183585.

When did Elitone Device receive FDA 510(k) clearance?

Elitone Device received FDA 510(k) clearance on 2019-02-11, under 510(k) number K183585.

Who is the listed applicant for Elitone Device?

The FDA 510(k) record lists Elidah, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elitone Device?

The FDA product code for Elitone Device is QAJ.

其他以 Elidah, Inc. 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。

K253285Elitone 男性用 K223884ELITONE 緊急尿失禁設備

相關器械（代碼：QAJ）

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。

K253285Elitone 男性用Elidah, Inc.K223884ELITONE 緊急尿失禁設備Elidah, Inc.K192357INNOVOAtlantic Therapeutics, Ltd.

官方來源

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