The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Ep Navigator Software.
| Device ID | K062650 |
| 510k Number | K062650 |
| Device Name: | EP NAVIGATOR SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS MEDICAL SYSTEMS 22100 BOTHELL EVERETT HWY Bothell, WA 98041 |
| Contact | Lynn Harmer |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-09-07 |
| Decision Date | 2006-09-21 |
| Summary: | summary |