Atlas Stim Headbox (NK) (31-0601-0077) +9 more— 510(k) K250094
Substantially EquivalentNeuralynx, Inc.
FDA 510(k) clearance K250094 for Atlas Stim Headbox (NK) (31-0601-0077) +9 more, Substantially Equivalent on 2025-04-14. Applicant: Neuralynx, Inc.. Device class: 2.
Clearance details
- Device name as filed
- Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)
- Applicant
- Neuralynx, Inc.
- Product code
- Code GYC
- Device class
- Class 2
- Regulation
- 21 CFR 882.1310
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bozeman, MT, US
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More clearances from Neuralynx, Inc.
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