Nellcor PM10N (2022)

We categorize devices as fingertip, handheld, benchtop, multimodal, phone-based or wearable.

Some devices may have capability to function as transmission and reflectance modes using different probe types. Read more about the difference between reflectance and transmittance devices in our FAQ.

This indicates the intended patient populations for the device (adult, pediatrics, neonates), as specified by our review of the manufacturers' published specifications. Use in certain patient populations may require procurement of a separate probe.

This indicates the location where the device is manufactured as stated by the manufacturer (or the stated location of the manufacturer). Please note, devices may contain components manufactured in different location.

"Ingress Protection" ratings define levels of sealing effectiveness of devices from foreign bodies (e.g. dust) and moisture. Read more at our FAQ.

Here we report retail purchase costs (US $) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

Here we try to report device features such as signal quality indicator, waveform, carboxy-Hb, perfusion index and ability to measure Hb.

Root mean square error (Arms) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601. Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in >10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see how details on how many subjects have been tested as well as details of skin color testing.

Currently, there is lack of consensus on optimal sample sizes for validation study cohorts. 2017 ISO and 2013 FDA documents stipulate at least 10 subjects, 15% of whom should be darkly pigmented.

Currently, there is lack of consensus on optimal methods for characterizing skin pigment and optimal sample sizes for validation study cohorts. 2017 ISO and 2013 FDA documents stipulate at least 10 subjects, 15% of whom should be darkly pigmented. Here we define ‘darkly pigmented’ as Monk Skin Tone Scale HIJ and Individual Typology Angle <-30.

This is the date that the Open Oximetry collected data in the UCSF Hypoxia Lab data to 'verify' or 'dispute' device performance. If Arms data were obtained from a source other than the Hypoxia Lab, please review the date for that source. Of note, device performance may be specific to a model year (even if the model name has not changed).

Root mean square error (Arms) is a common measure of pulse oximeter device performance. 'Arms' may be ascertained from manufacturers' published data, 510k reports, package inserts or primary data from testing conducted by the UCSF Hypoxia Lab. Devices independently tested by the Open Oximetry Project will be marked 'verified' or 'disputed' depending on study findings.

FDA 510k approval. Read more about FDA and 510k approvals on our FAQ.

Open Oximetry attempts to request CE certificates from manufacturers and distributors though this is not always possible. Read more about CE marking in our FAQ..

When available, here we show data on the forehead color for healthy volunteer subjects on which the device was tested. Each square represents a single study subject. The square's color is the RGB color derived from the L*a*b* color space using a Konica Minolta CM700d reflectance spectrophotometer. More info on skin color quantification.