The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Innova 2000 And Innova 2000s (mobile Version).
| Device ID | K024200 |
| 510k Number | K024200 |
| Device Name: | INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION) |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
| 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 | 2002-12-20 |
| Decision Date | 2003-01-16 |
| Summary: | summary |