510(k) K904392 ยท JAF Monitor, Ultrasonic, Nonfetal
MULTILAB 2000
| Applicant | Unetixs, Inc., Providence RI, US |
| Decision | Substantially Equivalent, Apr 29, 1991 |
| Received | Sep 24, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904392
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2023 | Unetixs Vascular, Inc. MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01 Open, Classified |
JAF | None listed |
| Mar 1, 2023 | Unetixs Vascular, Inc. MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01 Open, Classified |
JAF | None listed |
| Mar 1, 2023 | Unetixs Vascular, Inc. MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01 Open, Classified |
JAF | None listed |
| Mar 1, 2023 | Unetixs Vascular, Inc. MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01 Open, Classified |
JAF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.