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FDA 510(k)

Trinias

K-Number: K221922 · 2022-07-28

ApplicantShimadzu Corporation Medical Systems Division
Decision Date2022-07-28
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Shimadzu Corporation Medical Systems Division as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240827SET-5002

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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