The following data is part of a premarket notification filed by Philips Medical Systems North America Co. with the FDA for Flxis.
| Device ID | K050692 |
| 510k Number | K050692 |
| Device Name: | FLXIS |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Contact | Lynn Harmer |
| Correspondent | Lynn Harmer PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-17 |
| Decision Date | 2005-04-08 |
| Summary: | summary |