The following data is part of a premarket notification filed by Nuclear Assoc., Div. Inovision Lp with the FDA for Cal/rad Mark Iv-dose Calibrator 34-162 Veenstra Model # Vdc-304.
| Device ID | K010417 |
| 510k Number | K010417 |
| Device Name: | CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 |
| Classification | Calibrator, Dose, Radionuclide |
| Applicant | NUCLEAR ASSOC., DIV. INOVISION LP 100 VOICE RD. Carle Place, NY 11514 |
| Contact | Christine G Castleberry |
| Correspondent | Christine G Castleberry NUCLEAR ASSOC., DIV. INOVISION LP 100 VOICE RD. Carle Place, NY 11514 |
| Product Code | KPT |
| CFR Regulation Number | 892.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-12 |
| Decision Date | 2001-04-26 |