510(k) K951764 ยท IYE Accelerator, Linear, Medical
UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR
| Applicant | Ptw-New York Corp., Bellmore NY, US |
| Decision | Substantially Equivalent, Oct 7, 1995 |
| Received | Apr 17, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951764
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2015 | PTW-Freiburg PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics. Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.