The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Heartnavigator Release 2.0.
| Device ID | K140138 |
| 510k Number | K140138 |
| Device Name: | HEARTNAVIGATOR RELEASE 2.0 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 3959 VAN DYKE ROAD, SUITE 245 Lutz, FL 33558 |
| Contact | Michael Dayton |
| Correspondent | Michael Dayton PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 3959 VAN DYKE ROAD, SUITE 245 Lutz, FL 33558 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-22 |
| Decision Date | 2014-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838080744 | K140138 | 000 |
| 00884838059207 | K140138 | 000 |