The following data is part of a premarket notification filed by Medtel Pty. Ltd. with the FDA for D668 & D664 Central Monitoring Systems.
| Device ID | K800243 |
| 510k Number | K800243 |
| Device Name: | D668 & D664 CENTRAL MONITORING SYSTEMS |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | MEDTEL PTY. LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-05 |
| Decision Date | 1980-04-10 |