510(k) K101264 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
TEMPUS IC PROFESSIONAL PATIENT MONITOR
| Applicant | Remote Diagnostic Technologies , Ltd., Hampshire, GB |
| Decision | Substantially Equivalent, May 11, 2010 |
| Received | May 5, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101264
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2011 | Remote Diagnostic Technologies Ltd. TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT.
Indicated for 3 Lead ECG mo Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.