MasterX 800 Series— 510(k) K230918
Substantially EquivalentMedicatech USA
FDA 510(k) clearance K230918 for MasterX 800 Series, Substantially Equivalent on 2023-09-01. Applicant: Medicatech USA. Device class: 2.
Clearance details
- Applicant
- Medicatech USA
- Product code
- Code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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