BRIUS Planner Software— 510(k) K212828

Name: FDA 510(k) clearance K212828
Creator: U.S. Food and Drug Administration
Published: 2021-10-01

Substantially Equivalent

Brius Technologies, Inc.

FDA 510(k) clearance K212828 for BRIUS Planner Software, Substantially Equivalent on 2021-10-01. Applicant: Brius Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Brius Technologies, Inc.
Product code: Code PNN
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2021-09-03
Decision date: 2021-10-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Carrollton, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.