FDA 510(k)

維博斯安230

K 號：K212035 · 2021-07-30

決定日期2021-07-30

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

FibroScan 230 is the device name listed in this FDA 510(k) record. The listed applicant is Echosens. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K212035. 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 230?

FibroScan 230 is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Echosens. The 510(k) number is K212035.

When did FibroScan 230 receive FDA 510(k) clearance?

FibroScan 230 received FDA 510(k) clearance on 2021-07-30, under 510(k) number K212035.

Who is the listed applicant for FibroScan 230?

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 230?

The FDA product code for FibroScan 230 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。

K223902FibroScan®設備（型號：502 Touch、530 Compact、430 Mini+、230 和 630）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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