MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM
FDA 510(k) clearance K021988 · decided 2002-08-29
Clearance details
- K-number
- K021988
- Device name
- MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM
- Applicant
- Medrad, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-06-18
- Decision date
- 2002-08-29
- Days to decision
- 72 days
- Clearance type
- Abbreviated
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Indianola, PA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Continuum MR Compatible Infusion Pump. Pump Model #3009135 recall (Z-0841-05) | Medrad Inc | 2005-05-13 |