The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Ep Navigator Rel. 5.0.
| Device ID | K142126 |
| 510k Number | K142126 |
| Device Name: | EP NAVIGATOR REL. 5.0 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best, NL 5684 Pc |
| Contact | Liselotte Kornmann |
| Correspondent | Hans Venings PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best, NL 5684 Pc |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-04 |
| Decision Date | 2014-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838059184 | K142126 | 000 |