510(k) K081277 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
| Applicant | Medtronic Xomed, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Sep 5, 2008 |
| Received | May 5, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081277
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2021 | Medtronic Xomed, Inc. Software 1898072 IPC upgrade v 2.7.3.0, IPC System:
a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC Terminated |
ERL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.