| Device Type ID | 5260 |
| Device Name | System, Telethermographic, Infrared |
| Regulation Description | Telethermographic System. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | PMA |
| CFR Regulation Number | 884.2980 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | IYM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5260 |
| Device | System, Telethermographic, Infrared |
| Product Code | IYM |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Telethermographic System. |
| CFR Regulation Number | 884.2980 [🔎] |