The following data is part of a premarket notification filed by Philips Medical Systems North America Co. with the FDA for Practix Convenio.
| Device ID | K042368 |
| 510k Number | K042368 |
| Device Name: | PRACTIX CONVENIO |
| Classification | System, X-ray, Mobile |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 22100 BOTHELL EVERETT HIGHWAY Bothell, WA 98021 -8431 |
| Contact | Lynn Harmer |
| Correspondent | Lynn Harmer PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 22100 BOTHELL EVERETT HIGHWAY Bothell, WA 98021 -8431 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-31 |
| Decision Date | 2004-10-04 |
| Summary: | summary |