| Device Type ID | 5371 |
| Device Name | Calibrator, Dose, Radionuclide |
| Regulation Description | Radionuclide Dose Calibrator. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.1360 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KPT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5371 |
| Device | Calibrator, Dose, Radionuclide |
| Product Code | KPT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Radionuclide Dose Calibrator. |
| CFR Regulation Number | 892.1360 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COMECER NETHERLANDS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VARINAK ONKOLOJI SISTEMLERI SATIS VE SERVIS A.S. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |