FDA 510(k)

超音波傳感器蓋

K 號：K241662 · 2024-08-30

決定日期2024-08-30

產品代碼ITX

諮詢委員會RA

決定相當於

器材摘要

Ultrasound Transducer Cover is the device name listed in this FDA 510(k) record. The listed applicant is Vitrolife Sweden AB. It received FDA 510(k) clearance on 2024-08-30 under 510(k) number K241662. 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 Ultrasound Transducer Cover?

Ultrasound Transducer Cover is a medical device that received FDA 510(k) clearance on 2024-08-30. The listed applicant is Vitrolife Sweden AB. The 510(k) number is K241662.

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

Ultrasound Transducer Cover received FDA 510(k) clearance on 2024-08-30, under 510(k) number K241662.

Who is the listed applicant for Ultrasound Transducer Cover?

The FDA 510(k) record lists Vitrolife Sweden AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultrasound Transducer Cover?

The FDA product code for Ultrasound Transducer Cover is ITX.

其他以 Vitrolife Sweden AB 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。

K243373胚胎移植針管組合：EmbryoCath 胚胎移植針管 - 預曲 230 mm (參考編號 17500)；EmbryoCath 胚胎移植針管 - 直型可塑 180 mm (參考編號 17501)；EmbryoCath 胚胎移植針管 - 直型可塑 230 mm (參考編號 17502)；EmbryoCath 射針 - 180 mm (參考編號 17510)；EmbryoCath 射針 - 230 mm (參考編號 17511)K240605Ultra RapidWarm™ Blast K202862Gx-IVF, Gx-TL, Gx-MOPS PLUS K183486RapidVit™ 卵母細胞，RapidWarm™ 卵母細胞 K181461Rapid-i™ 套件 K172050毛囊抽吸套組，減少單腔

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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

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