ALLIVE— 510(k) K192773

Name: FDA 510(k) clearance K192773
Creator: U.S. Food and Drug Administration
Published: 2019-12-06

Substantially Equivalent

Nu Eyne Co., Ltd.

FDA 510(k) clearance K192773 for ALLIVE, Substantially Equivalent on 2019-12-06. Applicant: Nu Eyne Co., Ltd.. Device class: 2.

Clearance details

Applicant: Nu Eyne Co., Ltd.
Product code: Code PCC
Device class: Class 2
Regulation: 21 CFR 882.5891
Advisory panel: Neurology
Date received: 2019-09-30
Decision date: 2019-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code PCC

product code PCC

Other: 1
Total: 1

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.