The following data is part of a premarket notification filed by Remote Diagnostic Technologies Ltd. with the FDA for Tempusic Patient Monitor.
| Device ID | K082718 |
| 510k Number | K082718 |
| Device Name: | TEMPUSIC PATIENT MONITOR |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. THE AVENUE, FARLEIGH WALLOP Basingstoke, Hampshire, GB Rg25 2ht |
| Contact | Chris Hannan |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-09-17 |
| Decision Date | 2008-10-10 |
| Summary: | summary |