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FDA 510(k)

BRIUS Planner Software

K-Number: K212828 · 2021-10-01

ApplicantBrius Technologies, Inc.
Decision Date2021-10-01
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRIUS Planner Software is a medical device manufactured by Brius Technologies, Inc.. It received FDA 510(k) clearance on 2021-10-01 under approval number K212828. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRIUS Planner Software?

BRIUS Planner Software is a medical device that received FDA 510(k) clearance on 2021-10-01. It is manufactured by Brius Technologies, Inc.. The 510(k) number is K212828.

When was BRIUS Planner Software approved by the FDA?

BRIUS Planner Software received FDA 510(k) clearance on 2021-10-01, under approval number K212828.

What company makes BRIUS Planner Software?

BRIUS Planner Software is manufactured by Brius Technologies, Inc..

What is the FDA product code for BRIUS Planner Software?

The FDA product code for BRIUS Planner Software is PNN.

Other Devices by Brius Technologies, Inc.

K202792BRIUS Clear Aligners

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Official Source

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