Puritan Bennett Cuff Pressure Manager
FDA 510(k) clearance K202874 · decided 2021-01-09
Clearance details
- K-number
- K202874
- Device name
- Puritan Bennett Cuff Pressure Manager
- Applicant
- Covidien, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-09-28
- Decision date
- 2021-01-09
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- BSK
- Device class
- 2
- Regulation number
- 868.5750
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Puritan Bennett Cuff Pressure Manager, REF: 180-03 recall (Z-2651-2023) | Covidien | 2023-09-29 |
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 |