eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)— 510(k) K223446

Name: FDA 510(k) clearance K223446
Creator: U.S. Food and Drug Administration
Published: 2023-01-18

Substantially Equivalent

Signifier Medical Technologies, Ltd.

FDA 510(k) clearance K223446 for eXciteOSA without remote control (3000); eXciteOSA with remote control (6000), Substantially Equivalent on 2023-01-18. Applicant: Signifier Medical Technologies, Ltd.. Device class: 2.

Clearance details

Applicant: Signifier Medical Technologies, Ltd.
Product code: Code QNO
Device class: Class 2
Regulation: 21 CFR 872.5575
Advisory panel: Dental
Date received: 2022-11-15
Decision date: 2023-01-18
Decision: Substantially Equivalent
Clearance type: Special
Location: London, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code QNO

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K240328 — eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)2024-05-16
DEN200018 — eXciteOSA with remote and eXciteOSA without remote2021-02-05

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