Jumong General— 510(k) K230241

Substantially Equivalent

Sg Healthcare Co, Ltd.

FDA 510(k) clearance K230241 for Jumong General, Substantially Equivalent on 2023-02-23. Applicant: Sg Healthcare Co, Ltd..

Clearance details

Applicant: Sg Healthcare Co, Ltd.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2023-01-30
Decision date: 2023-02-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.