| Device Type ID | 6054 |
| Device Name | Devices, Breath Trapping, Alcohol |
| Regulation Description | Breath-alcohol Test System. |
| Regulation Medical Specialty | Toxicology |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.3050 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | DJZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |