The following data is part of a premarket notification filed by Remote Diagnostic Technologies Ltd with the FDA for Tempus Pro With Enhanced Features.
| Device ID | K133973 |
| 510k Number | K133973 |
| Device Name: | TEMPUS PRO WITH ENHANCED FEATURES |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | REMOTE DIAGNOSTIC TECHNOLOGIES LTD THE OLD COACH HOUSE, THE AVENUE, FARLEIGH WALLOP Basingstoke, GB Rg252ht |
| Contact | Leigh Cornock |
| Correspondent | Leigh Cornock REMOTE DIAGNOSTIC TECHNOLOGIES LTD THE OLD COACH HOUSE, THE AVENUE, FARLEIGH WALLOP Basingstoke, GB Rg252ht |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-26 |
| Decision Date | 2014-08-14 |
| Summary: | summary |