The following data is part of a premarket notification filed by Ge Dec Medical Systems with the FDA for Series 7700 Mobile C-arm, Compact 7700 Mobile C-arm, Compact 7700 Plus Mobile C-arm.
| Device ID | K000221 |
| 510k Number | K000221 |
| Device Name: | SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE DEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
| Contact | Ted L Parrot |
| Correspondent | Monica Morrison GE DEC MEDICAL SYSTEMS P.O. Box 7550 Madison, WI 53707 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-24 |
| Decision Date | 2000-04-11 |