FDA-Device2021-02-24Class II
SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital sensor (V-Sign Sensor 2 or OxiVenT sensor).
SenTec AG
Hazard
Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
Sold states
IL, PA, FL, NJ, GA, MA
Affected count
15 devices
Manufactured in
Ringstrasse 39, N/A, Therwil, N/A, Switzerland
Products
SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital sensor (V-Sign Sensor 2 or OxiVenT sensor).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1134-2021Don't want to check this manually?
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