HORIZON LIGHT
FDA 510(k) clearance K994375 · decided 2000-03-08
Clearance details
- K-number
- K994375
- Device name
- HORIZON LIGHT
- Applicant
- B.Braun Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-12-27
- Decision date
- 2000-03-08
- Days to decision
- 72 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 |
|---|---|---|
| Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used recall (Z-2188-2013) | B Braun Medical, Inc. | 2013-09-13 |
| Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used recall (Z-2175-2013) | B Braun Medical, Inc. | 2013-09-10 |
| Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used recall (Z-0051-2012) | B Braun Medical, Inc | 2011-10-18 |
| Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES B. recall (Z-0007-2012) | B Braun Medical, Inc | 2011-10-03 |
| Outlook 400ES Safety Infusion System, Model Number 621-400ES. For use with B. Braun Medica recall (Z-0837-2011) | B Braun Medical, Inc | 2011-01-10 |