AUTO SYRINGE AS40A INFUSION PUMP
FDA 510(k) clearance K940147 · decided 1994-04-15
Clearance details
- K-number
- K940147
- Device name
- AUTO SYRINGE AS40A INFUSION PUMP
- Applicant
- Baxter Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-01-11
- Decision date
- 1994-04-15
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Round Lake, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Baxter Auto Syringe AS40 and AS40A Infusion Pump, product code 1M8565 (pumps with drug lib recall (Z-0599-06) | Baxter Healthcare Corp. | 2006-03-07 |