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 | K130773 |
| 510k Number | K130773 |
| Device Name: | TEMPUS PRO PATIENT MONITOR |
| 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 | Chris Hannan |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-03-20 |
| Decision Date | 2013-06-05 |
| Summary: | summary |