CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304
Device Facts
| Record ID | K010417 |
|---|---|
| Device Name | CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 |
| Applicant | Nuclear Assoc., Div. Inovision LP |
| Product Code | KPT · Radiology |
| Decision Date | Apr 26, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1360 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.
