The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Innova And Innova 2000 S.
| Device ID | K022322 |
| 510k Number | K022322 |
| Device Name: | INNOVA AND INNOVA 2000 S |
| 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 | 2002-07-17 |
| Decision Date | 2002-10-08 |
| Summary: | summary |