510(k) K090296 ยท KPT Calibrator, Dose, Radionuclide
ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336
| Applicant | Biodex Medical Systems, Inc., Shirley NY, US |
| Decision | Substantially Equivalent, Feb 19, 2009 |
| Received | Feb 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090296
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 16, 2021 | Biodex Medical Systems, Inc. Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive
Model: 086-330. Terminated |
KPT | None listed |
| Aug 16, 2021 | Biodex Medical Systems, Inc. AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive
Model: 086-332 Terminated |
KPT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.