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ATLAS-HS-36-CHET-D18

NEURALYNX, INC. · Model ATLAS-HS-36-CHET-D18 · UDI-DI 00867718000292

GWL Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The ATLAS-HS-36-CHET-D18 is a clinical headstage that allows two 18 contact DIXI electrode connectors to interface with the ATLAS Data Acquisition System. The ATLAS-HS-36-CHET-D18 uses electronic components to buffer single unit activity sensed by the electrodes and sends it to the ATLAS Data Acquisition System to be digitized.

Recalls

Date	Firm	Reason
2016-08-10	Blackrock Microsystems, LLC	Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient
2016-08-10	Blackrock Microsystems, LLC	Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient
2013-02-27	Natus Neurology Incorporated	Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overhea
2010-03-26	I2s Micro Implantable Systems Llc	Component of cranial array may not allow sufficient tightening to maintain inserter position.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.