FDA 510(k)

FibroScan® 630

K 號：K200655 · 2020-07-16

決定日期2020-07-16

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

FibroScan® 630 is the device name listed in this FDA 510(k) record. The listed applicant is Echosens. It received FDA 510(k) clearance on 2020-07-16 under 510(k) number K200655. 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® 630?

FibroScan® 630 is a medical device that received FDA 510(k) clearance on 2020-07-16. The listed applicant is Echosens. The 510(k) number is K200655.

When did FibroScan® 630 receive FDA 510(k) clearance?

FibroScan® 630 received FDA 510(k) clearance on 2020-07-16, under 510(k) number K200655.

Who is the listed applicant for FibroScan® 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® 630?

The FDA product code for FibroScan® 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。

K223902FibroScan®設備（型號：502 Touch、530 Compact、430 Mini+、230 和 630）K212035維博斯安230 K203273FibroScan® 產品系列（型號：502 Touch、530 Compact、430 Mini+ 及 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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