The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Ge Xtreme Injector Option.
| Device ID | K082960 |
| 510k Number | K082960 |
| Device Name: | GE XTREME INJECTOR OPTION |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. W706 Waukesha, WI 53188 |
| Contact | Steven Kachelmeyer |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-10-03 |
| Decision Date | 2008-10-17 |
| Summary: | summary |