510(k) K042920 ยท ITI Wheelchair, Powered
HOVEROUND SE-3 POWERCHAIR
| Applicant | Hoveround Corp., Sarasota FL, US |
| Decision | Substantially Equivalent, Dec 3, 2004 |
| Received | Oct 22, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042920
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2006 | Abbott Laboratories MPG ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
DDR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.