The following data is part of a premarket notification filed by Electromek Diagnostic Systems, Inc. with the FDA for G.e. Dxd 325/350/350ii/dxd 525/525ii Generators.
| Device ID | K902986 |
| 510k Number | K902986 |
| Device Name: | G.E. DXD 325/350/350II/DXD 525/525II GENERATORS |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | ELECTROMEK DIAGNOSTIC SYSTEMS, INC. 412 ROUTE 40 WEST Troy, IL 62294 |
| Contact | James Henrichs |
| Correspondent | James Henrichs ELECTROMEK DIAGNOSTIC SYSTEMS, INC. 412 ROUTE 40 WEST Troy, IL 62294 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-26 |
| Decision Date | 1991-02-13 |