510(k) K071396 ยท KPT Calibrator, Dose, Radionuclide
CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS
| Applicant | Capintec, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent, Jun 28, 2007 |
| Received | May 21, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071396
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2011 | Capintec Inc Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02
PET dose calibrator Terminated |
KPT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.