FDA 510(k)

SaliPen

K 號：K220618 · 2022-08-30

決定日期2022-08-30

產品代碼QTT

諮詢委員會DE

決定相當於

器材摘要

SaliPen is the device name listed in this FDA 510(k) record. The listed applicant is Saliwell , Ltd.. It received FDA 510(k) clearance on 2022-08-30 under 510(k) number K220618. The device is classified under product code QTT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SaliPen?

SaliPen is a medical device that received FDA 510(k) clearance on 2022-08-30. The listed applicant is Saliwell , Ltd.. The 510(k) number is K220618.

When did SaliPen receive FDA 510(k) clearance?

SaliPen received FDA 510(k) clearance on 2022-08-30, under 510(k) number K220618.

Who is the listed applicant for SaliPen?

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

What is the FDA product code for SaliPen?

The FDA product code for SaliPen is QTT.

其他以 Saliwell , 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。

K232063SaliPen K180838SaliPen K160799GenNarino

相關器械（代碼：QTT）

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。

K232063SaliPenSaliwell , Ltd.

官方來源

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