Jumong Series— 510(k) K150816

Name: FDA 510(k) clearance K150816
Creator: U.S. Food and Drug Administration
Published: 2015-05-08

Substantially Equivalent

Sg Healthcare Co, Ltd.

FDA 510(k) clearance K150816 for Jumong Series, Substantially Equivalent on 2015-05-08. Applicant: Sg Healthcare Co, Ltd.. Device class: 2.

Clearance details

Applicant: Sg Healthcare Co, Ltd.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2015-03-27
Decision date: 2015-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hanam-Si Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

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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.