UNOMEDICAL MONICA INFUSION SET
FDA 510(k) clearance K032854 · decided 2003-10-09
Clearance details
- K-number
- K032854
- Device name
- UNOMEDICAL MONICA INFUSION SET
- Applicant
- Unomedical A/S
- Decision
- Substantially Equivalent
- Date received
- 2003-09-12
- Decision date
- 2003-10-09
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Roskilde, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, recall (Z-1810-2022) | Unomedical A/S | 2022-09-26 |