INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)
FDA 510(k) clearance K211561 · decided 2021-12-05
Clearance details
- K-number
- K211561
- Device name
- INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)
- Applicant
- Covidien, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-05-20
- Decision date
- 2021-12-05
- Days to decision
- 199 days
- Clearance type
- Traditional
- Product code
- MUD
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boulder, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC recall (Z-1731-2024) | Covidien | 2024-04-30 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S012) | Covidien, LLC | 2005-06-24 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S011) | Covidien, LLC | 2005-02-25 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S006) | Covidien, LLC | 2003-01-07 |
| OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S009) | Covidien, LLC | 2002-11-25 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S008) | Covidien, LLC | 2002-11-25 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S010) | Covidien, LLC | 2002-11-15 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S005) | Covidien, LLC | 2002-06-28 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S007) | Covidien, LLC | 2002-04-18 |