FDA-Device2022-05-25Class II
ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to investigational use. Only for use in Non-Significant Risk studies under the supervision of an IRB.
Neuralynx Inc
Hazard
Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufacturer does not have an approved IDE by the FDA. The product has not undergone electrical safety testing and has not received regulatory clearance.
Sold states
U.S. Nationwide distribution in the states of AL, CA, IL, MN, NC, RI.
Affected count
15
Manufactured in
105 Commercial Dr, N/A, Bozeman, MT, United States
Products
ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to investigational use. Only for use in Non-Significant Risk studies under the supervision of an IRB.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1091-2022Don't want to check this manually?
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