Neuralytix iD3 System (NTX-9001)— 510(k) K243636
Substantially EquivalentNeuralytix, LLC
FDA 510(k) clearance K243636 for Neuralytix iD3 System (NTX-9001), Substantially Equivalent on 2025-06-26. Applicant: Neuralytix, LLC. Device class: 2.
Clearance details
- Applicant
- Neuralytix, LLC
- Product code
- Code PDQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.1820
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fruita, CO, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.