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FDA 510(k)

Biotres

K-Number: K222017 · 2022-07-28

ApplicantBiotricity
Decision Date2022-07-28
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Biotres is a medical device manufactured by Biotricity. It received FDA 510(k) clearance on 2022-07-28 under approval number K222017. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biotres?

Biotres is a medical device that received FDA 510(k) clearance on 2022-07-28. It is manufactured by Biotricity. The 510(k) number is K222017.

When was Biotres approved by the FDA?

Biotres received FDA 510(k) clearance on 2022-07-28, under approval number K222017.

What company makes Biotres?

Biotres is manufactured by Biotricity.

What is the FDA product code for Biotres?

The FDA product code for Biotres is MWJ.

Other Devices by Biotricity

Related Devices (Code: MWJ)

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.