INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
FDA 510(k) clearance K083689 · decided 2009-07-01
Clearance details
- K-number
- K083689
- Device name
- INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
- Applicant
- B.Braun Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-12-12
- Decision date
- 2009-07-01
- Days to decision
- 201 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Carrollton, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp recall (Z-0623-2013) | B. Braun Medical, Inc. | 2012-12-31 |
| Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G0 recall (Z-1992-2012) | B. Braun Medical, Inc. | 2012-07-16 |
| B. Braun Infusomat Space Pump - US Version Infusion pump. Model number 8713050U. recall (Z-1015-2012) | B. Braun Medical, Inc. | 2012-02-29 |