The following data is part of a premarket notification filed by Eureka X-ray Tube Corp. with the FDA for Eureka Extension Cylinders.
| Device ID | K904489 |
| 510k Number | K904489 |
| Device Name: | EUREKA EXTENSION CYLINDERS |
| Classification | Device, Beam Limiting, X-ray, Diagnostic |
| Applicant | EUREKA X-RAY TUBE CORP. 600 W. UNIVERSITY DR. Arlington Heights, IL 60004 |
| Contact | Raymond Olson |
| Correspondent | Raymond Olson EUREKA X-RAY TUBE CORP. 600 W. UNIVERSITY DR. Arlington Heights, IL 60004 |
| Product Code | KPW |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-02 |
| Decision Date | 1990-10-15 |