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FDA 510(k)

Bioflux Software

K-Number: K162571 · 2016-10-13

ApplicantBiotricity, Inc.
Decision Date2016-10-13
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bioflux Software is a medical device manufactured by Biotricity, Inc.. It received FDA 510(k) clearance on 2016-10-13 under approval number K162571. 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?

Bioflux Software is a medical device that received FDA 510(k) clearance on 2016-10-13. It is manufactured by Biotricity, Inc.. The 510(k) number is K162571.

When was Bioflux Software approved by the FDA?

Bioflux Software received FDA 510(k) clearance on 2016-10-13, under approval number K162571.

What company makes Bioflux Software?

Bioflux Software is manufactured by Biotricity, Inc..

What is the FDA product code for Bioflux Software?

The FDA product code for Bioflux Software is DSH.

Other Devices by Biotricity, Inc.

K172311BioFlux Device

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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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