The following data is part of a premarket notification filed by American Executive Technology with the FDA for Wellshire Emlink Model 1000.
| Device ID | K890508 |
| 510k Number | K890508 |
| Device Name: | WELLSHIRE EMLINK MODEL 1000 |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | AMERICAN EXECUTIVE TECHNOLOGY 9601 WHITE ROCK TRAIL SUITE 105 Dallas, TX 75238 |
| Contact | Jerry Roberts |
| Correspondent | Jerry Roberts AMERICAN EXECUTIVE TECHNOLOGY 9601 WHITE ROCK TRAIL SUITE 105 Dallas, TX 75238 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-01 |
| Decision Date | 1989-03-02 |