The following data is part of a premarket notification filed by Remote Diagnostic Technologies Limited with the FDA for Tempus Pro Patient Monitor.
| Device ID | K201746 |
| 510k Number | K201746 |
| Device Name: | Tempus Pro Patient Monitor |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Remote Diagnostic Technologies Limited Pavilion C2, Ashwood Park, Ashwood Way Basingstoke, GB Rg23 8bg |
| Contact | Timothy Bubb |
| Correspondent | Neha Hardiya Philips North America LLC 22100 Bothell Everett Highway Bothell, WA 98021 |
| Product Code | MHX |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRG |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSB |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| Subsequent Product Code | MNR |
| Subsequent Product Code | MWI |
| Subsequent Product Code | NSX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-26 |
| Decision Date | 2020-09-18 |