IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM
FDA 510(k) clearance K894842 · decided 1989-09-12
Clearance details
- K-number
- K894842
- Device name
- IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM
- Applicant
- Imed Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-31
- Decision date
- 1989-09-12
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10 recall (Z-1770-2019) | Becton Dickinson & Company | 2019-07-11 |