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DEVICE DETAILS

NAME OF DEVICEMIGHTYSAT FINGERTIP PULSE OXIMETERS
ESTABLISHMENT NAMENYPRAX BUSINESS SOLUTIONS
REGISTRATION NOGC8596221-51719
BRAND NAMEMASIMO
DESCRIPTIONThe 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.
INTENDED PURPOSEThe 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 REGISTRATION06-01-2021 - 05-01-2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1MightySat Rx Fingertip Pulse Oximeter, non bluetooth9707
2MightySat Rx Fingertip Pulse Oximeter, bluetooth9807
3MightySat Rx Fingertip Pulse Oximeter, bluetooth and PVI9907
4MightySat Fingertip Pulse Oximeter, non bluetooth9701
5MightySat, fingertip pulse oximeter, bluetooth9801
6MightySat, fingertip pulse oximeter, bluetooth and PVI9901
7MightySat Rx Fingertip Pulse Oximeter9709
8MightySat Rx Fingertip Pulse Oximeter9909
9MightySat Rx Fingertip Pulse Oximeter 9809
10Masimo Profesion Health App IOS24714
11Masimo Profesion Health App (Andrioid)24716
12iSpO2 Rx (Android)24717
13iSpO2 Rx App(iOS)24715