The following data is part of a premarket notification filed by Electromek Diagnostic Systems, Inc. with the FDA for G.e. Polarix Ii C-arm.
| Device ID | K902982 |
| 510k Number | K902982 |
| Device Name: | G.E. POLARIX II C-ARM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| 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 | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-26 |
| Decision Date | 1990-11-13 |