510(k) K010436 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011
| Applicant | Remote Diagnostic Technologies , Ltd., Basingstoke, Hampshire, GB |
| Decision | Substantially Equivalent, May 14, 2001 |
| Received | Feb 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010436
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.