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Atlas Stim Headbox - Atlas Headbox Interface Cable (HD) (31-0204-005)
FDA 510(k)Class II (US FDA 510(k))
510(k) K250094
Identifiers
- 510(k) Number
- K250094 FDA 510(k)
- FDA Product Code
- GYC FDA 510(k)
- Models / Variants
- Atlas Stim Headbox (NK) (31-0601-0077) FDA 510(k)Atlas Stim Headbox (HD) (31-0601-0132) FDA 510(k)ATLAS Stim Headbox Software (36-0301-0006) FDA 510(k)Atlas Headbox Interface Cable (HD) (31-0204-005) FDA 510(k)Atlas Headbox Expansion Panel (31-0607-0014) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1310 FDA 510(k)
- Regulation Number
- 882.1310 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Atlas Stim Headbox - Atlas Headbox Interface Cable (HD) (31-0204-005) by Neuralynx, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 10 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250094 | Class II | Active |
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Manufacturer
- Manufacturer
- Neuralynx, Inc.
Sources (1)
- FDA 510(k) K250094 24 fields · synced Oct 9, 2026