FDA 510(k)

BRIUS Planner Software

K-Number: K212828 · 2021-10-01

Decision Date2021-10-01

Product CodePNN

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

BRIUS Planner Software is the device name listed in this FDA 510(k) record. The listed applicant is Brius Technologies, Inc.. It received FDA 510(k) clearance on 2021-10-01 under 510(k) 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. The listed applicant is Brius Technologies, Inc.. The 510(k) number is K212828.

When did BRIUS Planner Software receive FDA 510(k) clearance?

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

Who is the listed applicant for BRIUS Planner Software?

The FDA 510(k) record lists Brius Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRIUS Planner Software?

The FDA product code for BRIUS Planner Software is PNN.

Other records listing Brius Technologies, Inc. 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.

K202792BRIUS Clear Aligners

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Official Source

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