The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Innova 2100.
| Device ID | K050489 |
| 510k Number | K050489 |
| Device Name: | INNOVA 2100 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-02-25 |
| Decision Date | 2005-03-11 |
| Summary: | summary |