The following data is part of a premarket notification filed by Ge Oec Medical Systems, Inc with the FDA for Oec(r) 9800, Oec(r) 9800 Plus.
| Device ID | K111551 |
| 510k Number | K111551 |
| Device Name: | OEC(R) 9800, OEC(R) 9800 PLUS |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE OEC MEDICAL SYSTEMS, INC 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
| Contact | Gerald Buss |
| Correspondent | Gerald Buss 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 | 2011-06-03 |
| Decision Date | 2011-10-04 |
| Summary: | summary |