The following data is part of a premarket notification filed by Remote Diagnostic Technologies Ltd. with the FDA for Tempus Pro Accessories (ultrasound & Video Laryngoscope Probe).
| Device ID | K134014 |
| 510k Number | K134014 |
| Device Name: | TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) |
| 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 | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-30 |
| Decision Date | 2014-08-12 |
| Summary: | summary |