FDA 510(k)

EsoCheck 細胞收集裝置

K 號：K222366 · 2022-10-26

決定日期2022-10-26

產品代碼EOX

諮詢委員會中文(台灣): 此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。公司名稱：[公司名稱] 產品名稱：[產品名稱]

決定Unknown

器材摘要

EsoCheck Cell Collection Device is the device name listed in this FDA 510(k) record. The listed applicant is Lucid Diagnostics, Inc.. It received FDA 510(k) clearance on 2022-10-26 under 510(k) number K222366. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Unknown.

常見問題

What is the EsoCheck Cell Collection Device?

EsoCheck Cell Collection Device is a medical device that received FDA 510(k) clearance on 2022-10-26. The listed applicant is Lucid Diagnostics, Inc.. The 510(k) number is K222366.

When did EsoCheck Cell Collection Device receive FDA 510(k) clearance?

EsoCheck Cell Collection Device received FDA 510(k) clearance on 2022-10-26, under 510(k) number K222366.

Who is the listed applicant for EsoCheck Cell Collection Device?

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

What is the FDA product code for EsoCheck Cell Collection Device?

The FDA product code for EsoCheck Cell Collection Device is EOX.

其他以 Lucid Diagnostics, 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。

K230339EsoCheck 細胞收集裝置 K210137EsoCheck 細胞收集裝置 K183262EsoCheck CCD 細胞收集裝置

相關器械（代碼：EOX）

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。

K233142EndoSign® 細胞收集器 (ES-CYT-102)Cyted Limited K230339EsoCheck 細胞收集裝置Lucid Diagnostics, Inc.K223072PENTAX醫療內視鏡食道鏡 EE17-J10Pentax of America, Inc.K203450EsophaCap 可吞咽性細胞回收設備（原名 Cell-Mata）Capnostics, LLC K210137EsoCheck 細胞收集裝置Lucid Diagnostics, Inc.K192523CMOS 電子內視鏡喉鏡 SSUKarl Storz SE & CO. KG

官方來源

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