FDA-Device2021-07-28Class II
AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.
Mediana Co., Ltd.
Hazard
In some cases the equipment fails to power up and/or key or button unresponsive or not working.
Sold states
US Distribution to: Wisconsin only
Affected count
618
Manufactured in
132 Donghwagongdan-Ro, Munmag-Eup, Wonju, N/A, Korea (the Republic of)
Products
AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2096-2021Don't want to check this manually?
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