FDA-Device2021-02-03Class II
PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies.
Nihon Kohden America Inc
Hazard
Medical device non-conformance to electrical safety standard (IEC 60601-1).
Sold states
US Nationwide Distribution - CA, CO, CT, FL, ID, IL, IN, MA, MD, MI, MO, NC, NM, NY, SC, TX, TN, UT, VA, VT and WA.
Affected count
189 Units
Manufactured in
90 Icon, Foothill Ranch, CA, United States
Products
PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0865-2021Don't want to check this manually?
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