3M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION)
FDA 510(k) clearance K940446 · decided 1994-08-15
Clearance details
- K-number
- K940446
- Device name
- 3M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION)
- Applicant
- Minnesota Mining and Mfg. Co.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1994-02-01
- Decision date
- 1994-08-15
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Deltec 3000 Large Volume Infusion Pump, CE 0473, RX Only, Smiths Medical MD, Inc. 1265 Gre recall (Z-1604-2008) | Smiths Medical MD, Inc. | 2008-09-23 |
| Deltec Micro 3100 Large Volume Infusion Pump, CE 0473, RX Only, Smiths Medical MD, Inc. 12 recall (Z-1605-2008) | Smiths Medical MD, Inc. | 2008-09-23 |