EQ-PEX— 510(k) K210789

Name: FDA 510(k) clearance K210789
Creator: U.S. Food and Drug Administration
Published: 2021-10-20

Substantially Equivalent

Meta Systems Co., Ltd.

FDA 510(k) clearance K210789 for EQ-PEX, Substantially Equivalent on 2021-10-20. Applicant: Meta Systems Co., Ltd.. Device class: Unclassified.

Clearance details

Applicant: Meta Systems Co., Ltd.
Product code: Code LQY
Device class: Unclassified
Advisory panel: Unknown
Date received: 2021-03-16
Decision date: 2021-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

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K242765 — Electronic Apex Locator (Alpha Apex I)2025-01-17
K231990 — Apex Locator2024-02-13
K232717 — Apex Locator (AL-Pex), Apex Locator (AL-Pex+)2023-12-22

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Adverse events under product code LQY

product code LQY

Malfunction: 504
Total: 504

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.