FDA 510(k)

ARIETTA 65

K 號：K181376 · 2018-07-18

申請人Hitachi Healthcare Americas Corporation

決定日期2018-07-18

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

ARIETTA 65 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Healthcare Americas Corporation. It received FDA 510(k) clearance on 2018-07-18 under 510(k) number K181376. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ARIETTA 65?

ARIETTA 65 is a medical device that received FDA 510(k) clearance on 2018-07-18. The listed applicant is Hitachi Healthcare Americas Corporation. The 510(k) number is K181376.

When did ARIETTA 65 receive FDA 510(k) clearance?

ARIETTA 65 received FDA 510(k) clearance on 2018-07-18, under 510(k) number K181376.

Who is the listed applicant for ARIETTA 65?

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

What is the FDA product code for ARIETTA 65?

The FDA product code for ARIETTA 65 is IYN.

其他以 Hitachi Healthcare Americas Corporation 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。

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相關器械（代碼：IYN）

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。

官方來源

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