FDA-Device2019-05-15Class I
Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.
Alpha Omega Engineering
Hazard
If cables are improperly connected, current may reach high charge density, causing tissue harm.
Sold states
US nationwide distribution: AL, AZ, CA, CO, GA, IL, LA, MD, MA, MI, MN, OH, PA, RI, TX, and VA
Affected count
29
Manufactured in
PO Box 810, Haavoda Street, N/A, Nazerat Illit, N/A, Israel
Products
Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1216-2019Don't want to check this manually?
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