Artemis, Artemis TPO, Artemis MX— 510(k) K222222
Substantially EquivalentEigen
FDA 510(k) clearance K222222 for Artemis, Artemis TPO, Artemis MX, Substantially Equivalent on 2023-10-12. Applicant: Eigen. Device class: 2.
Clearance details
- Applicant
- Eigen
- Product code
- Code QTZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grass Valley, CA, US
Recent devices under product code QTZ
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