HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP
FDA 510(k) clearance K033054 · decided 2003-12-16
Clearance details
- K-number
- K033054
- Device name
- HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP
- Applicant
- Harvard Clinical Technology
- Decision
- Substantially Equivalent
- Date received
- 2003-09-29
- Decision date
- 2003-12-16
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- MEA
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- South Natick, MA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Harvard 1 Single Channel Syringe Infusion Pump, P/N 2003-001 recall (Z-0432-05) | Harvard Clinical Technology | 2005-01-26 |
| Harvard 2 Syringe Pump manufactured for Rita Medical (OEM) Model Number 2005-001 recall (Z-0433-05) | Harvard Clinical Technology | 2005-01-26 |