NeurotriS (SX2500); NeurotriS (SX3800)— 510(k) K251909
Substantially EquivalentA-1 Engineering
FDA 510(k) clearance K251909 for NeurotriS (SX2500); NeurotriS (SX3800), Substantially Equivalent on 2025-09-03. Applicant: A-1 Engineering. Device class: 2.
Clearance details
- Applicant
- A-1 Engineering
- 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
- Irvine, CA, US
Recent devices under product code NFO
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