The following data is part of a premarket notification filed by Ge Oec Medical Systems with the FDA for Oec 9800 Plus Digital Mobile Imaging System.
| Device ID | K021049 |
| 510k Number | K021049 |
| Device Name: | OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE OEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
| Contact | Bill Gislason |
| Correspondent | Bill Gislason GE OEC MEDICAL SYSTEMS 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 | 2002-04-01 |
| Decision Date | 2002-04-17 |
| Summary: | summary |