DC-Air and Athlos-1 and Athlos-Air— 510(k) K211688

Substantially Equivalent

Athlos OY

FDA 510(k) clearance K211688 for DC-Air and Athlos-1 and Athlos-Air, Substantially Equivalent on 2021-07-22. Applicant: Athlos OY. Device class: 2.

Clearance details

Applicant: Athlos OY
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2021-06-02
Decision date: 2021-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Espoo, FI

Download summary PDF View on FDA.gov ↗

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