PHILIPS EASYDIAGNOST ELEVA
FDA 510(k) clearance K031535 · decided 2003-06-17
Clearance details
- K-number
- K031535
- Device name
- PHILIPS EASYDIAGNOST ELEVA
- Applicant
- Philips Medical Systems North America Co.
- Decision
- Substantially Equivalent
- Date received
- 2003-05-16
- Decision date
- 2003-06-17
- Days to decision
- 32 days
- Clearance type
- Special
- Product code
- KPR
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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