FDA 510(k)

FibroScan®設備（型號：502 Touch、530 Compact、430 Mini+、230 和 630）

K 號：K223902 · 2023-03-02

決定日期2023-03-02

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) is the device name listed in this FDA 510(k) record. The listed applicant is Echosens. It received FDA 510(k) clearance on 2023-03-02 under 510(k) number K223902. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)?

FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) is a medical device that received FDA 510(k) clearance on 2023-03-02. The listed applicant is Echosens. The 510(k) number is K223902.

When did FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) receive FDA 510(k) clearance?

FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) received FDA 510(k) clearance on 2023-03-02, under 510(k) number K223902.

Who is the listed applicant for FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)?

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

What is the FDA product code for FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)?

The FDA product code for FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) is IYO.

其他以 Echosens 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。

K212035維博斯安230 K203273FibroScan® 產品系列（型號：502 Touch、530 Compact、430 Mini+ 及 630）K200655FibroScan® 630 K181547FibroScan® 產品系列（型號：502 Touch、530 Compact 及 430 Mini+）K173034FibroScan® 產品系列（型號：502 Touch、530 Compact 及 430 Mini+）K172142FibroScan 430 Mini+

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相關器械（代碼：IYO）

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。

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官方來源

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