The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for Ski 5000.
| Device ID | K812646 |
| 510k Number | K812646 |
| Device Name: | SKI 5000 |
| Classification | Echocardiograph |
| Applicant | SMITH KLINE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-17 |
| Decision Date | 1981-11-16 |