Medical Monitor (32HR734S)— 510(k) K241402

Substantially Equivalent

Lg Electronics.Inc

FDA 510(k) clearance K241402 for Medical Monitor (32HR734S), Substantially Equivalent on 2024-08-12. Applicant: Lg Electronics.Inc.

Clearance details

Applicant: Lg Electronics.Inc
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2024-05-17
Decision date: 2024-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gumi-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.