FDA 510(k)

Trinias

K 號：K221922 · 2022-07-28

申請人Shimadzu Corporation Medical Systems Division

決定日期2022-07-28

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

Trinias is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corporation Medical Systems Division. It received FDA 510(k) clearance on 2022-07-28 under 510(k) number K221922. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Trinias?

Trinias is a medical device that received FDA 510(k) clearance on 2022-07-28. The listed applicant is Shimadzu Corporation Medical Systems Division. The 510(k) number is K221922.

When did Trinias receive FDA 510(k) clearance?

Trinias received FDA 510(k) clearance on 2022-07-28, under 510(k) number K221922.

Who is the listed applicant for Trinias?

The FDA 510(k) record lists Shimadzu Corporation Medical Systems Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Trinias?

The FDA product code for Trinias is OWB.

其他以 Shimadzu Corporation Medical Systems Division 為申請人之記錄

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K240827SET-5002

相關器械（代碼：OWB）

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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