Definium Pace Select— 510(k) K231892

Substantially Equivalent

Ge Hualun Medical Systems Co. , Ltd.

FDA 510(k) clearance K231892 for Definium Pace Select, Substantially Equivalent on 2023-09-12. Applicant: Ge Hualun Medical Systems Co. , Ltd..

Clearance details

Applicant: Ge Hualun Medical Systems Co. , Ltd.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2023-06-28
Decision date: 2023-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

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.