(169 days)
PM601 Finger pulse oximeter is intended for spot-checking oxygen saturation in blood (SpO2) and pulse rate. The pulse oximeter is used on adults at hospital, clinics, and/or home. Not for continuously monitoring.
The proposed device, Finger Pulse Oximeters PM601 is a fingertip device, which can display % SpO2. pulse rate value and pulse strength. It is based on digital blood oxygen. Power consumption of the proposed device is low and the two originally-equipped AAA alkaline batteries can be operated continuously for 24 hours. It will automatically turned off when no signal is detected for more than 8 seconds. And low voltage warning will be displayed and battery symbol flash when battery voltage is low.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Predicate Device) | Reported Device Performance (PM601) |
|---|---|---|
| SpO2 measurement range | 70%-100% | 70%-100% |
| SpO2 accuracy | 70%~100%, ±3% |
§ 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).