Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array— 510(k) K261442
Substantially EquivalentCadwell Industries, Inc.
FDA 510(k) clearance K261442 for Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array, Substantially Equivalent on 2026-06-26. Applicant: Cadwell Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Cadwell Industries, Inc.
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Kennewick, WA, US
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