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Amplitude-Integrated Electroencephalograph

FDA product code OMA · Class 2 · Neurology

76
Registered devices
4
Adverse events
3
Recalls
16
510(k) clearances

Devices with this code

NA — NIHON KOHDEN AMERICA, INC.CARDINAL HEALTH — Cardinal Health 200, LLCComponent Neuromonitoring System — MOBERG RESEARCH INCComponent Neuromonitoring System — MOBERG RESEARCH INCNA — NIHON KOHDEN AMERICA, INC.Persyst Mobile App — Persyst Development CorpNA — NIHON KOHDEN CORPORATIONNatus — XLTEKComponent Monitoring System — MOBERG RESEARCH INCComponent Neuromonitoring System — MOBERG RESEARCH INCComponent Neuromonitoring System — MOBERG RESEARCH INCNA — NIHON KOHDEN CORPORATIONNatus — XLTEKNA — NIHON KOHDEN CORPORATIONXltek — XLTEKComponent Neuromonitoring System — MOBERG RESEARCH INCNatus — XLTEKNA — NIHON KOHDEN CORPORATIONNatus — XLTEKPersyst Mobile App — Persyst Development CorpNatus — XLTEKComponent Neuromonitoring System — MOBERG RESEARCH INCPersyst 12 EEG Review and Analysis Software — Persyst Development CorpNeuroMatch — LVIS CORPORATION

Recent recalls

DateFirmReason
2025-05-07Natus Neurology DBA Excel Tech., Ltd. (XLTEK)Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates
2023-02-20Moberg Research, Inc.Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin. D
2020-03-05Natus Neurology DBA Excel Tech., Ltd. (XLTEK)The OBM system functional test (impedance and noise) was not carried out on the affected items prior to release to the customer. The manufacturer cannot attest

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.