eXciteOSA with remote and eXciteOSA without remote— 510(k) DEN200018

Name: FDA 510(k) clearance DEN200018
Creator: U.S. Food and Drug Administration
Published: 2021-02-05

Unknown

Signifier Medical Technologies

FDA 510(k) clearance DEN200018 for eXciteOSA with remote and eXciteOSA without remote, Unknown on 2021-02-05. Applicant: Signifier Medical Technologies. Device class: 2.

Clearance details

Applicant: Signifier Medical Technologies
Product code: Code QNO
Device class: Class 2
Regulation: 21 CFR 872.5575
Advisory panel: Dental
Date received: 2020-03-24
Decision date: 2021-02-05
Decision: Unknown
Clearance type: Direct
Location: London, GB

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
K223446 — eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)2023-01-18

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