| Device Type ID | 109 |
| Device Name | Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling |
| Regulation Description | Indwelling Blood Hydrogen Ion Concentration (pH) Analyzer. |
| 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 | 868.1170 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CBZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 109 |
| Device | Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling |
| Product Code | CBZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Indwelling Blood Hydrogen Ion Concentration (pH) Analyzer. |
| CFR Regulation Number | 868.1170 [🔎] |