510(k) K130773 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
TEMPUS PRO PATIENT MONITOR
| Applicant | Remote Diagnostic Technologies , Ltd., Hampshire, GB |
| Decision | Substantially Equivalent, Jun 5, 2013 |
| Received | Mar 20, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130773
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2025 | Remote Diagnostic Technologies Ltd. Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer) Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.