LG SMARTHEALTH— 510(k) K133997

Substantially Equivalent

Lg Electronics

FDA 510(k) clearance K133997 for LG SMARTHEALTH, Substantially Equivalent on 2014-11-21. Applicant: Lg Electronics.

Clearance details

Applicant: Lg Electronics
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2013-12-27
Decision date: 2014-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.