The following data is part of a premarket notification filed by Remote Diagnostic Technologies Ltd with the FDA for Tempus Pro Patient Monitor.
| Device ID | K170567 |
| 510k Number | K170567 |
| Device Name: | Tempus Pro Patient Monitor |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Remote Diagnostic Technologies Ltd Pavilion C2, Ashwood Park, Ashwood Way Basingstoke, GB Rg23 8bg |
| Contact | Chris Hannan |
| Correspondent | Chris Hannan Remote Diagnostic Technologies Ltd Pavilion C2, Ashwood Park, Ashwood Way Basingstoke, GB Rg23 8bg |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-27 |
| Decision Date | 2017-07-06 |
| Summary: | summary |