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FDA 510(k)

Bioflux Software II

K-Number: K201040 · 2020-07-29

ApplicantBiotricity
Decision Date2020-07-29
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bioflux Software II is a medical device manufactured by Biotricity. It received FDA 510(k) clearance on 2020-07-29 under approval number K201040. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bioflux Software II?

Bioflux Software II is a medical device that received FDA 510(k) clearance on 2020-07-29. It is manufactured by Biotricity. The 510(k) number is K201040.

When was Bioflux Software II approved by the FDA?

Bioflux Software II received FDA 510(k) clearance on 2020-07-29, under approval number K201040.

What company makes Bioflux Software II?

Bioflux Software II is manufactured by Biotricity.

What is the FDA product code for Bioflux Software II?

The FDA product code for Bioflux Software II is DSH.

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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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