(29 days)
The Nellcor N-200 pulse oximeter is intended for non-invasive, continuous, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate, and pulse amplitude. This device is for prescription use only.
The Nellcor N-200 Pulse Oximeter provides continuous non-invasive measurement and display of pulse rate and oxygen saturation values with visual and audible alarms, and features C-Lock, Nellcor's patented ECG Synchronization technology which reduces motion artifact. The N-200 Pulse Oximeter functions with all Nellcor reusable and disposable oximeter sensors.
This Special 510(k) covers the labeling modification of Nellcor N-200 Pulse Oximeter that was cleared under 510(k) #K863784. The modification involves revising the N-200 labeling to add performance specifications for motion and low perfusion when the N-200 is used with C-Lock ECG synchronization. Results from clinical evaluation are provided to support the labeling change. No device modifications have been made to the N-200. The labeling change does not affect the intended use or alter the fundamental scientific technology of the device.
The furnished document is a 510(k) summary for the Nellcor N-200 Pulse Oximeter, which is a re-submission of a previously cleared device. The summary states that the current submission is for a labeling change to add performance specifications for motion and low perfusion when the N-200 is used with C-Lock ECG synchronization. It also indicates that no device modifications were made.
Therefore, the document does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria in the format requested. The document mentions that "clinical evaluation" was provided to support the labeling change, but it does not detail these clinical evaluations, their methodology, or their results in this summary.
To answer your request, more detailed clinical study reports would be needed beyond what is provided in this 510(k) summary.
§ 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).