Aura Glide (FC40)— 510(k) K252187
Substantially EquivalentAura Medical, LLC
FDA 510(k) clearance K252187 for Aura Glide (FC40), Substantially Equivalent on 2025-12-23. Applicant: Aura Medical, LLC. Device class: 2.
Clearance details
- Applicant
- Aura Medical, LLC
- Product code
- Code NFO
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brooklyn, NY, US
Recent devices under product code NFO
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