The following data is part of a premarket notification filed by Ge Healthcare Surgery with the FDA for Oec 9900 Elite.
| Device ID | K082781 |
| 510k Number | K082781 |
| Device Name: | OEC 9900 ELITE |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE HEALTHCARE SURGERY 384 WRIGHT BROTHERS DRIVE Salt Lake City, UT 84116 |
| Contact | Maria C Frame |
| Correspondent | Maria C Frame GE HEALTHCARE SURGERY 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-22 |
| Decision Date | 2009-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682114301 | K082781 | 000 |