FDA 510(k)

ALOKA ARIETTA 850

K 號：K173739 · 2018-02-28

申請人Hitachi Healthcare Americas Corporation

決定日期2018-02-28

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

ALOKA ARIETTA 850 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 2018-02-28 under 510(k) number K173739. 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 ALOKA ARIETTA 850?

ALOKA ARIETTA 850 is a medical device that received FDA 510(k) clearance on 2018-02-28. The listed applicant is Hitachi Healthcare Americas Corporation. The 510(k) number is K173739.

When did ALOKA ARIETTA 850 receive FDA 510(k) clearance?

ALOKA ARIETTA 850 received FDA 510(k) clearance on 2018-02-28, under 510(k) number K173739.

Who is the listed applicant for ALOKA ARIETTA 850?

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 ALOKA ARIETTA 850?

The FDA product code for ALOKA ARIETTA 850 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。

K181376ARIETTA 65 K172110ECHELON 橢圓 V6.0A 體掃描系統 K171708ALOKA ARIETTA 850 K171738Supria 真實64

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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