MEDEX 3000 SERIES SYRINGE INFUSION PUMP
FDA 510(k) clearance K982640 · decided 1999-04-06
Clearance details
- K-number
- K982640
- Device name
- MEDEX 3000 SERIES SYRINGE INFUSION PUMP
- Applicant
- Medex, Inc.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1998-07-29
- Decision date
- 1999-04-06
- Days to decision
- 251 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Hilliard, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4 recall (Z-0768-2007) | Smiths Medical MD, Inc. | 2007-04-26 |