(88 days)
Replacement battery for Nellcor, Inc. 0810-0115 N-100 Pulse Oximeter, 510(k) Number K822909.
This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
Replacement Battery Part Number GL0810-0115
The provided text is a 510(k) premarket notification letter from the FDA to Alexander Manufacturing Company regarding a replacement battery. This document primarily focuses on regulatory approval and does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot extract the requested information to fill in the table or answer the questions related to device performance studies. The document only states that the device is "substantially equivalent" to legally marketed predicate devices.
§ 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).