Definium Tempo Select— 510(k) K250788
Substantially EquivalentGe Hualun Medical Systems Co. , Ltd.
FDA 510(k) clearance K250788 for Definium Tempo Select, Substantially Equivalent on 2025-08-28. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beijing, CN
Adverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
Source: openFDA MAUDE database, through . 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.