The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Advantage Windows With Functool Option.
| Device ID | K960265 |
| 510k Number | K960265 |
| Device Name: | ADVANTAGE WINDOWS WITH FUNCTOOL OPTION |
| Classification | System, Image Processing, Radiological |
| Applicant | GE MEDICAL SYSTEMS 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-18 |
| Decision Date | 1996-07-03 |
| Summary: | summary |