SE INFUSION SYSTEM WITH MMS
FDA 510(k) clearance K043590 · decided 2005-03-25
Clearance details
- K-number
- K043590
- Device name
- SE INFUSION SYSTEM WITH MMS
- Applicant
- Cardinal Health, Alaris Products
- Decision
- Substantially Equivalent
- Date received
- 2004-12-28
- Decision date
- 2005-03-25
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Alaris SE Pump (formerly Signature Edition Infusion Pump); Model Numbers: 7000, 7100, 7101 recall (Z-1484-06) | Cardinal Health 303 Inc DBA Alaris Products | 2006-09-19 |