FDA-Device2025-07-30Class II
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Hazard
Natus received two complaints of left side labeling show impedance for right side.
Sold states
US: CA, IN, MO, NC, PA, RI, TX
Affected count
27 units
Manufactured in
2568 Bristol Cir, N/A, Oakville, N/A, Canada
Products
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2138-2025Don't want to check this manually?
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