MULTILAB 2000
FDA 510(k) clearance K904392 · decided 1991-04-29
Clearance details
- K-number
- K904392
- Device name
- MULTILAB 2000
- Applicant
- Unetixs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-09-24
- Decision date
- 1991-04-29
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- JAF
- Device class
- 2
- Regulation number
- 892.1540
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Providence, RI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number recall (Z-1193-2023) | Unetixs Vascular, Inc. | 2023-03-01 |
| MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 119 recall (Z-1194-2023) | Unetixs Vascular, Inc. | 2023-03-01 |
| MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000 recall (Z-1195-2023) | Unetixs Vascular, Inc. | 2023-03-01 |
| MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-0 recall (Z-1196-2023) | Unetixs Vascular, Inc. | 2023-03-01 |