DEVICE DETAILS
| NAME OF DEVICE | MIGHTYSAT FINGERTIP PULSE OXIMETERS |
|---|---|
| ESTABLISHMENT NAME | NYPRAX BUSINESS SOLUTIONS |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC8596221-51719 |
| BRAND NAME | MASIMO |
| MEDICAL DEVICE CATEGORY | MD 1300 - MONITORING DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The MightySat Fingertip Pulse Oximeter are designed for noninvasive spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2), Pulse Rate (PR), and Perfusion Index (PI), and Pleth Variability Index (PVI), and optional Respiratory Rate from the Pleth (RRp). The following key features are available for the MightySat Rx: • Masimo SET technology for SpO2 and pulse rate monitoring in motion and low perfusion environments. • Optional Bluetooth LE wireless technology for the wireless transfer of patient data to smart devices. |
| DEVICE INTENDED PURPOSE | The Masimo MightySat Rx Fingertip Pulse Oximeter is intended for hospitals, hospital-type facilities, home environments, and transport. The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused. The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for the noninvasive spot checking of respiration rate (RRp) for adult patients. |
| VALIDITY DATE OF REGISTRATION | 06/01/2021 - 05/01/2026 |