The following data is part of a premarket notification filed by Ge Oec Medical Systems with the FDA for Flexiview 8800 Digital Mobile Imaging System.
| Device ID | K003837 |
| 510k Number | K003837 |
| Device Name: | FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | GE OEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
| Contact | Ted Parrot |
| Correspondent | Ted Parrot GE OEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-12 |
| Decision Date | 2001-03-12 |