2 results
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33ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.
FDA Enforcement
Class I
·Terminated·Alpha Omega Engineering·May 15, 2019
Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.
FDA Recall
Terminated
·Alpha Omega Engineering·Product code GZL·September 4, 2018