The following data is part of a premarket notification filed by Remote Diagnostic Technologies Ltd. with the FDA for Tempus 2000 Patient Monitor, Model 00-0001; Tempus Monitoring Station, Model 01-0011.
| Device ID | K010436 |
| 510k Number | K010436 |
| Device Name: | TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. THE AVENUE, FARLEIGH WALLOP Basingstoke, Hampshire, GB Rg25 2ht |
| Contact | Chris Hannan |
| Correspondent | Chris Hannan REMOTE DIAGNOSTIC TECHNOLOGIES LTD. THE AVENUE, FARLEIGH WALLOP Basingstoke, Hampshire, GB Rg25 2ht |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-13 |
| Decision Date | 2001-05-14 |