The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Innova 4100, Innova 3100.
| Device ID | K042053 |
| 510k Number | K042053 |
| Device Name: | INNOVA 4100, INNOVA 3100 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE MEDICAL SYSTEMS, INC. 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS, INC. 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-30 |
| Decision Date | 2004-08-26 |
| Summary: | summary |