The following data is part of a premarket notification filed by Remote Diagnostic Technologies Ltd. with the FDA for Tempusic Patient Monitor.
| Device ID | K113105 |
| 510k Number | K113105 |
| Device Name: | TEMPUSIC 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 | William Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-10-20 |
| Decision Date | 2011-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060472440709 | K113105 | 000 |
| 05060472440693 | K113105 | 000 |
| 05060472440686 | K113105 | 000 |
| 05060472440679 | K113105 | 000 |
| 05060472440600 | K113105 | 000 |