| Device Type ID | 143 |
| Device Name | Monitor, Carbon-dioxide, Cutaneous |
| Regulation Description | Cutaneous Carbon Dioxide (PcCO2) Monitor. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.2480 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LKD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 143 |
| Device | Monitor, Carbon-dioxide, Cutaneous |
| Product Code | LKD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cutaneous Carbon Dioxide (PcCO2) Monitor. |
| CFR Regulation Number | 868.2480 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SENTEC AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 19 |
Fracture | 4 |
Material Deformation | 3 |
Device Alarm System | 3 |
Thread | 3 |
Insufficient Information | 2 |
Break | 2 |
Entrapment Of Device | 2 |
Malposition Of Device | 2 |
Bolt | 2 |
Cups | 2 |
Device Deployer | 2 |
Handpiece | 1 |
Difficult To Remove | 1 |
Device Operates Differently Than Expected | 1 |
High Readings | 1 |
Screw | 1 |
Use Of Device Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Positioning Problem | 1 |
Failure To Disconnect | 1 |
Alarm, Audible | 1 |
Motor | 1 |
Detachment Of Device Component | 1 |
Sticking | 1 |
Analyzer | 1 |
Locking Mechanism | 1 |
| Total Device Problems | 61 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Philips Medical Systems, Inc. | II | Jan-16-2015 |
| 2 | Radiometer America Inc | II | May-02-2016 |
| 3 | Radiometer America Inc | II | Aug-19-2015 |
| 4 | SenTec AG | II | Oct-17-2016 |
| 5 | SenTec AG | II | Apr-22-2015 |