PHILIPS EASYDIAGNOST ELEVA— 510(k) K031535
Substantially EquivalentPhilips Medical Systems North America Co.
FDA 510(k) clearance K031535 for PHILIPS EASYDIAGNOST ELEVA, Substantially Equivalent on 2003-06-17. Applicant: Philips Medical Systems North America Co..
Clearance details
- Applicant
- Philips Medical Systems North America Co.
- Product code
- Code KPR
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bothell, WA, US
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.