(53 days)
The NC Adapter Cable with Nellcor sensors are indicated for the continuous noninvasive monitoring of functional I its readiner of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediation informator of Liveral In hospitals, hospitals, hospital-type facilities, mobile, and home environments.
The NC Adapter Cable is fully compatible oximetry cable that allows the use of Nellcor Sensors with Masimo SET Radical pulse oximeter monitors. The cable represents a design change to the Masimo patient cables and the MS board. The NC Adapter Cable is similar in construction to the predicate device enabling the Nellcor Sensors to be connected to Masimo SET Radical pulse oximeters. The NC Adapter Cable is designed, and manufactured for full compatibility with Masimo SET Radical pulse oximeters using Nellcor Sensors. The NC Adapter Cable is constructed of similar materials and components of equivalent specifications as used in the predicate devices.
Here's a summary of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated as "Accuracy of less than") | Reported Device Performance (Accuracy) | Measurement Range (SaO2) | Patient Population | Notes |
|---|---|---|---|---|
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).