FDA 510(k)

ALOKA LISENDO 880

K 號：K162583 · 2016-11-17

決定日期2016-11-17

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

ALOKA LISENDO 880 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi , Ltd.. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K162583. 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 LISENDO 880?

ALOKA LISENDO 880 is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Hitachi , Ltd.. The 510(k) number is K162583.

When did ALOKA LISENDO 880 receive FDA 510(k) clearance?

ALOKA LISENDO 880 received FDA 510(k) clearance on 2016-11-17, under 510(k) number K162583.

Who is the listed applicant for ALOKA LISENDO 880?

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

What is the FDA product code for ALOKA LISENDO 880?

The FDA product code for ALOKA LISENDO 880 is IYN.

其他以 Hitachi , Ltd. 為申請人之記錄

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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。

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