NeuroSpan Bridge— 510(k) K253363
Substantially EquivalentAuxilium Biotechnologies, Inc.
FDA 510(k) clearance K253363 for NeuroSpan Bridge, Substantially Equivalent on 2026-01-17. Applicant: Auxilium Biotechnologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Auxilium Biotechnologies, Inc.
- Product code
- Code JXI
- Device class
- Class 2
- Regulation
- 21 CFR 882.5275
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
Recent devices under product code JXI
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