HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO
FDA 510(k) clearance K991513 · decided 1999-06-21
Clearance details
- K-number
- K991513
- Device name
- HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO
- Applicant
- I-Flow Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-04-30
- Decision date
- 1999-06-21
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lake Forest, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Easypump LT 60-24 Easypump Infusion Pump (60 ml x 2 ml/hr) recall (Z-0741-03) | I-Flow Corporation | 2003-04-18 |