MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP
FDA 510(k) clearance K931549 · decided 1993-10-12
Clearance details
- K-number
- K931549
- Device name
- MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP
- Applicant
- Y
- Decision
- Substantially Equivalent
- Date received
- 1993-03-29
- Decision date
- 1993-10-12
- Days to decision
- 197 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 |