510(k) K083689 ยท FRN Pump, Infusion
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
| Applicant | B.Braun Medical, Inc., Carrollton TX, US |
| Decision | Substantially Equivalent, Jul 1, 2009 |
| Received | Dec 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083689
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 31, 2012 | B. Braun Medical, Inc. Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130.
The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole. Terminated |
FRN | None listed |
| Jul 16, 2012 | B. Braun Medical, Inc. Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102.
Intended for use with adults, pediatrics Terminated |
FRN | None listed |
| Feb 29, 2012 | B. Braun Medical, Inc. B. Braun Infusomat Space Pump - US Version Infusion pump. Model number 8713050U. Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.