The following data is part of a premarket notification filed by Remote Diagnostics Technologies Ltd with the FDA for Tempus Ic2.
| Device ID | K152124 |
| 510k Number | K152124 |
| Device Name: | Tempus IC2 |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | REMOTE DIAGNOSTICS TECHNOLOGIES LTD THE OLD COACH HOUSE, THE AVENUE, FARLEIGH WALLOP Basingstoke, GB Rg25 2ht |
| Contact | Chris Hannan |
| Correspondent | Chris Hannan REMOTE DIAGNOSTICS TECHNOLOGIES LTD THE OLD COACH HOUSE, THE AVENUE, FARLEIGH WALLOP Basingstoke, GB Rg25 2ht |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-31 |
| Decision Date | 2015-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060472440594 | K152124 | 000 |
| 05060472440501 | K152124 | 000 |
| 05060472440495 | K152124 | 000 |
| 05060472440488 | K152124 | 000 |
| 05060472440464 | K152124 | 000 |
| 05060472440457 | K152124 | 000 |
| 05060472440440 | K152124 | 000 |
| 05060472440433 | K152124 | 000 |
| 05060472442949 | K152124 | 000 |