510(k) K963703 ยท DPT Probe, Blood-Flow, Extravascular
ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)
| Applicant | International Biophysics Corp., Austin TX, US |
| Decision | Substantially Equivalent, Apr 8, 1998 |
| Received | Sep 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963703
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2006 | International Biophysics Corp IBC FloProbe (Non-sterile), a disposable flow probe that is used as a component of the Medtronic Bio-Console System. The Medtronic Bio-Console System is intended for use in the monitoring of the ex Terminated |
DPT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.