QUEX ED; QUEX S— 510(k) K232779

Substantially Equivalent

Qx World, Ltd.

FDA 510(k) clearance K232779 for QUEX ED; QUEX S, Substantially Equivalent on 2024-10-11. Applicant: Qx World, Ltd.. Device class: 2.

Clearance details

Applicant: Qx World, Ltd.
Product code: Code OMC
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2023-09-11
Decision date: 2024-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Budapest, HU

Download summary PDF View on FDA.gov ↗

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