RED— 510(k) K242304
Substantially EquivalentNeuraxis, Inc.
FDA 510(k) clearance K242304 for RED, Substantially Equivalent on 2024-12-06. Applicant: Neuraxis, Inc.. Device class: 2.
Clearance details
- Applicant
- Neuraxis, Inc.
- Product code
- Code KLA
- Device class
- Class 2
- Regulation
- 21 CFR 876.1725
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carmel, IN, US
Recent devices under product code KLA
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