The following data is part of a premarket notification filed by Ge Healthcare Surgery Ge Oec Medical Systems, Inc with the FDA for Oec 9900 Elite.
| Device ID | K122234 |
| 510k Number | K122234 |
| Device Name: | OEC 9900 ELITE |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC 384 WRIGHT BROTHERS DRIVE Salt Lake City, UT 84116 |
| Contact | Gerald Buss |
| Correspondent | Gerald Buss GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC 384 WRIGHT BROTHERS DRIVE 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-26 |
| Decision Date | 2012-08-16 |
| Summary: | summary |