510(k) K121347 ยท GXZ Electrode, Needle
PRESSON ELECTRODE
| Applicant | Rhythmlink International, LLC, Columbia SC, US |
| Decision | Substantially Equivalent, Jul 12, 2012 |
| Received | May 1, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121347
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2013 | Extremity Medical LLC Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010.
This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the sc Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.