| Device Type ID | 3388 |
| Device Name | Device, Gas Generating |
| Regulation Description | Gas-generating Device. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 866.2580 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KZJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3388 |
| Device | Device, Gas Generating |
| Product Code | KZJ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Gas-generating Device. |
| CFR Regulation Number | 866.2580 [🔎] |
| Device Problems | |
|---|---|
Fracture | 1 |
| Total Device Problems | 1 |