ELITE 5000— 510(k) K905501
Substantially EquivalentFischer Imaging Corp.
FDA 510(k) clearance K905501 for ELITE 5000, Substantially Equivalent on 1991-01-18. Applicant: Fischer Imaging Corp.. Device class: 2.
Clearance details
- Applicant
- Fischer Imaging Corp.
- Product code
- Code IXR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1980
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Addison, IL, US
Recent devices under product code IXR
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