The following data is part of a premarket notification filed by Tri W-g, Inc. with the FDA for Echocardiography.
| Device ID | K945163 |
| 510k Number | K945163 |
| Device Name: | ECHOCARDIOGRAPHY |
| Classification | Table, Examination, Medical, Powered |
| Applicant | TRI W-G, INC. P.O. BOX 905 Valley City, ND 58072 |
| Contact | David Kesler |
| Correspondent | David Kesler TRI W-G, INC. P.O. BOX 905 Valley City, ND 58072 |
| Product Code | LGX |
| CFR Regulation Number | 878.4960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-21 |
| Decision Date | 1995-02-17 |