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Covidien’s Nellcor Pulse Oximeters receive FDA 510(k) clearance

Patient monitoring and respiratory care devices provider Covidien's Nellcor Pulse Oximeters has obtained 510(k) clearance with labeling from US Food and Drug Administration (FDA).

Nellcor Pulse Oximeters facilitates in noninvasive screening of Critical Congenital Heart Disease (CCHD) in newborns.

Covidien Respiratory and Monitoring Solutions vice president and general manager Matthew Anderson said that CCHD is a life-threatening condition that can be detected and treated early through proper screening.

"Covidien is committed to raising public awareness about this issue and encouraging CCHD screenings," Anderson added.

As part of a broad effort to educate clinicians on the importance of CCHD screenings, Covidien has begun labeling and promoting the use of Nellcor pulse oximetry as a tool to aid healthcare practitioners in CCHD screening.

Nellcor pulse oximetry technology had demonstrated consistent performance during various conditions, including patient motion, noise and low perfusion that could obstruct the assessment of patients’ respiratory status.

Nellcor pulse oximetry technology provides accurate readings in neonates (+/-2% accuracy), mainly because it relies on cardiac-based signals to generate readings closely tied to the patient’s physiology.

Nellcor Pulse Oximeters are claimed to be the only oximeters on the market certified to be in compliance with ISO 80601-2-61 International Organization for Standardization.

Specific Covidien devices featuring the new CCHD labels include Nellcor Bedside SpO2 Patient Monitoring System, Nellcor Bedside Respiratory Patient Monitoring System, Nellcor N-600x Pulse Oximetry Monitoring System.