Pulse Oximeter PM-50

The Pulse Oximeter PM-50 is specifically designed for noninvasive, spot-check measurements of arterial hemoglobin oxygen saturation (SpO₂). While it provides real-time monitoring during use, it is not intended for continuous, long-term tracking as its primary function is to deliver discrete readings in clinical assessments. This makes it ideal for quick evaluations in settings like emergency rooms or intensive care units where intermittent checks are standard.

The PM-50 is supplied as a reusable medical instrument, meaning it is built for repeated use in clinical environments like hospitals. Since it is reusable, it requires proper calibration and maintenance as outlined in the manufacturer’s instructions to ensure accuracy and reliability. Unlike single-use devices, it does not have regulatory sterility requirements, but standard infection control protocols should still be followed during handling and between patients.

The PM-50 is authorized under FDA 510(k) clearance (K061442) and complies with the Medical Device Directive (MDD). Its regulatory submission was reviewed by the Cardiovascular (CV) Advisory Committee, specifically under the AN (Anesthesiology) review panel, to assess its equivalence to existing pulse oximetry devices. The clearance was granted as substantially equivalent (SESE) to predicate devices, adhering to cardiovascular standards for pulse oximetry applications.

While the PM-50 is intended for clinical environments like hospitals, emergency rooms, and intensive care units, its design—being reusable and requiring calibration—makes it more suitable for inpatient settings where infrastructure for maintenance and monitoring is readily available. Outpatient use would depend on the facility’s ability to meet the device’s operational and maintenance requirements, though the manufacturer’s instructions should be consulted for specific guidance.