510(k) K002833 ยท KPT Calibrator, Dose, Radionuclide
MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER
| Applicant | Standard Imaging, Inc., Middleton WI, US |
| Decision | Substantially Equivalent, Sep 28, 2000 |
| Received | Sep 12, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002833
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.