FDA 510(k)

FibroScan 530 精簡版

K 號：K160524 · 2016-03-18

決定日期2016-03-18

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

FibroScan 530 Compact is the device name listed in this FDA 510(k) record. The listed applicant is Echosens. It received FDA 510(k) clearance on 2016-03-18 under 510(k) number K160524. 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 530 Compact?

FibroScan 530 Compact is a medical device that received FDA 510(k) clearance on 2016-03-18. The listed applicant is Echosens. The 510(k) number is K160524.

When did FibroScan 530 Compact receive FDA 510(k) clearance?

FibroScan 530 Compact received FDA 510(k) clearance on 2016-03-18, under 510(k) number K160524.

Who is the listed applicant for FibroScan 530 Compact?

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 530 Compact?

The FDA product code for FibroScan 530 Compact 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）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+）

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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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