FDA-Device2015-08-05Class II

OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.

Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Hazard

Potential missing segments on the display that can result in misinterpretation of data.

Sold states
Worldwide Distribution - US Nationwide including Canada.
Affected count
105,831 units
Manufactured in
6135 Gunbarrel Ave, N/A, Boulder, CO, United States
Products
OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2268-2015

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