DEVICE DETAILS
| NAME OF DEVICE | NONIN MODEL 7500 PULSE OXIMETER AND ACCESSORIES |
|---|---|
| ESTABLISHMENT NAME | ACUCARE SYSTEMS (M) SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC4547419-36840 |
| BRAND NAME | NONIN MODEL 7500 PULSE OXIMETER AND ACCESSORIES |
| MEDICAL DEVICE CATEGORY | MD 1300 - MONITORING DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The Nonin Model 7500 Digital Pulse Oximeter is a portable, tabletop device indicated for use in measuring, displaying and recording functional oxygen saturation of arterial hemoglobin (SpO2) and puse rate of adult, pediatric, infant, and neonatal patients. it is indicated for spot-checking and/or continuous monitoring of patients during both motion and no-motion conditions, and for patients who are well or poorly perfused. The Nonin Model 7500FO Digital Pulse Oximeter is a portable, tabletop device indicated for use in simultaneously measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric and infant patients in an Magnetic Resonance (MR) environment while operating on battery power alone. Testing was performed in MR conditional environments at 1.5T and 3T. It is intended for spot checking and/or continuous monitoring of patients who are well or poorly perfused. |
| DEVICE INTENDED PURPOSE | The NONIN Model 7500 Digital Pulse Oximeter is a portable, tabletop device indicated for use in simultaneously measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant and neonatal patients. It is intended for spot-checking and/or continuous monitoring of patients during both motion and no-motion conditions, and for patients who are well or poorly perfused. The Nonin Model 7500FO Digital Pulse Oximeter is a portable, tabletop devie indicated for use in simultaneously measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric and infant patients ina Magnetic Resonance (MR) environment while operating on battery power alone. Testing was performed in MR conditional environments at 1.5T and 3T. It is intended for spot checking and/or continuous monitoring of patients who are well or poorly perfused. |
| VALIDITY DATE OF REGISTRATION | 28/11/2019 - 27/11/2024 |