Rayvolve PTX-PE— 510(k) K243808
Substantially EquivalentAZmed
FDA 510(k) clearance K243808 for Rayvolve PTX-PE, Substantially Equivalent on 2025-03-21. Applicant: AZmed. Device class: 2.
Clearance details
- Applicant
- AZmed
- Product code
- Code QFM
- Device class
- Class 2
- Regulation
- 21 CFR 892.2080
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Paris, FR
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