FDA 510(k)

傳感器探針蓋

K 號：K241615 · 2024-07-03

決定日期2024-07-03

產品代碼ITX

諮詢委員會RA

決定相當於

器材摘要

Transducer Probe Cover is the device name listed in this FDA 510(k) record. The listed applicant is Hony Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-07-03 under 510(k) number K241615. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Transducer Probe Cover?

Transducer Probe Cover is a medical device that received FDA 510(k) clearance on 2024-07-03. The listed applicant is Hony Medical Co., Ltd.. The 510(k) number is K241615.

When did Transducer Probe Cover receive FDA 510(k) clearance?

Transducer Probe Cover received FDA 510(k) clearance on 2024-07-03, under 510(k) number K241615.

Who is the listed applicant for Transducer Probe Cover?

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

What is the FDA product code for Transducer Probe Cover?

The FDA product code for Transducer Probe Cover is ITX.

其他以 Hony Medical 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。

K241789非無菌超聲傳播膠 K221278傳感器探針蓋 K221999超音波傳遞膠

相關器械（代碼：ITX）

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。

K260114Align® 覆蓋及墊材導引工具CIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm Corporation K254143EM-TECH 靜脈式超音波探頭帶EM-TECH Solutions, Inc.K260161SmartGuide 一次性導向器和網格UC-CARE , Ltd.K262474ND針導引系統Accurate Access, LLC K261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。