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Atlas Stim Headbox - ATLAS Stim Headbox Software (36-0301-0006)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250094

by Neuralynx, Inc.

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 (Touchproof) (31-0601-0089) FDA 510(k)
Atlas Stim Headbox (HD) (31-0601-0132) FDA 510(k)
ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001) FDA 510(k)
ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002) FDA 510(k)
ATLAS Stim Headbox Software (36-0301-0006) FDA 510(k)
Atlas Headbox Interface Cable (NK) (31-0204-003) FDA 510(k)
Atlas Headbox Interface Cable (Touchproof) (31-0204-004) 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 Stim Headbox Software (36-0301-0006) 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

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Manufacturer

Manufacturer
Neuralynx, Inc.

Sources (1)

  • FDA 510(k) K250094 24 fields · synced Oct 9, 2026