| Device Type ID | 226 |
| Device Name | Analyzer, Hydrogen Gas |
| 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) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | LXO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 226 |
| Device | Analyzer, Hydrogen Gas |
| Product Code | LXO |
| Device Problems | |
|---|---|
Loss Of Osseointegration | 1 |
Crack | 1 |
| Total Device Problems | 2 |