The following data is part of a premarket notification filed by Remote Diagnostic Technologies Ltd. with the FDA for Tempus Pro Extended Features.
| Device ID | K133988 |
| 510k Number | K133988 |
| Device Name: | TEMPUS PRO EXTENDED FEATURES |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. THE OLD COACH HOUSE, THE AV. FARLEIGH WALLOP, BASINGSTOKE Hampshire, GB Rg25 2ht |
| Contact | Leigh Cornock |
| Correspondent | Leigh Cornock REMOTE DIAGNOSTIC TECHNOLOGIES LTD. THE OLD COACH HOUSE, THE AV. FARLEIGH WALLOP, BASINGSTOKE Hampshire, GB Rg25 2ht |
| Product Code | MWI |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSB |
| Subsequent Product Code | DXN |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-26 |
| Decision Date | 2014-05-16 |
| Summary: | summary |