FDA 510(k)

Trinias

K号: K221922 · 2022-07-28

申请人Shimadzu Corporation Medical Systems Division

决定日期2022-07-28

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Shimadzu Corporation Medical Systems Division为申报人的其他记录

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K240827SET-5002

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