FDA-Device2020-04-08Class II
natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Hazard
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 to the system functionality of the affected items.
Sold states
Worldwide distribution. US nationwide, Australia, Dominican Republic, United Arab Emirates, Israel, Italy, Hong Kong, Korea, Hungary, Switzerland, Colombia, and United Kingdom
Affected count
40 units
Manufactured in
2568 Bristol Cir, N/A, Oakville, N/A, Canada
Products
natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1630-2020Don't want to check this manually?
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