The following data is part of a premarket notification filed by Ge Oec Medical Systems, Inc. with the FDA for Ge Oec Fluorostar.
| Device ID | K043076 |
| 510k Number | K043076 |
| Device Name: | GE OEC FLUOROSTAR |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE OEC MEDICAL SYSTEMS, INC. 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
| Contact | Jeff Wagner |
| Correspondent | Jeff Wagner GE OEC MEDICAL SYSTEMS, INC. 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-08 |
| Decision Date | 2004-12-22 |