510(k) K011975 ยท FRN Pump, Infusion
HORIZON OUTLOOK WITH DOSECOM
| Applicant | B.Braun Medical, Inc., Carrollton TX, US |
| Decision | Substantially Equivalent, Sep 19, 2001 |
| Received | Jun 25, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011975
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 13, 2013 | B Braun Medical, Inc. Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system i Terminated |
FRN | None listed |
| Oct 18, 2011 | B Braun Medical, Inc Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system i Terminated |
FRN | None listed |
| Oct 3, 2011 | B Braun Medical, Inc Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES
B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006
The Outlook ES pump is intended for Terminated |
FRN | None listed |
| Jan 10, 2011 | B Braun Medical, Inc Outlook 400ES Safety Infusion System, Model Number 621-400ES. For use with B. Braun Medical Inc. Horizon Pump IV Sets Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.