MR Q; MR Q SUPINE; MR Q SLT— 510(k) K232417

Name: FDA 510(k) clearance K232417
Creator: U.S. Food and Drug Administration
Published: 2024-01-25

Substantially Equivalent

Meridian AG

FDA 510(k) clearance K232417 for MR Q; MR Q SUPINE; MR Q SLT, Substantially Equivalent on 2024-01-25. Applicant: Meridian AG. Device class: 2.

Clearance details

Applicant: Meridian AG
Product code: Code HQF
Device class: Class 2
Regulation: 21 CFR 886.4390
Advisory panel: Ophthalmic
Date received: 2023-08-11
Decision date: 2024-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thun, CH

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HQF

product code HQF

Injury: 166
Other: 1
Total: 167

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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