| Device Type ID | 4 |
| Device Name | Analyzer, Gas, Helium, Gaseous-phase |
| Regulation Description | Helium Gas 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) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.1640 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BSE |
| 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 | 4 |
| Device | Analyzer, Gas, Helium, Gaseous-phase |
| Product Code | BSE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Helium Gas Analyzer. |
| CFR Regulation Number | 868.1640 [🔎] |