EchoNavigator
System, Image Processing, Radiological
Philips Medical Systems Nederland B.V.
The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Echonavigator.
Pre-market Notification Details
| Device ID | K200713 |
| 510k Number | K200713 |
| Device Name: | EchoNavigator |
| Classification | System, Image Processing, Radiological |
| Applicant | Philips Medical Systems Nederland B.V. Veenpluis 6 Best, NL 5684 Pc |
| Contact | Ioana Ulea |
| Correspondent | Ioana Ulea Philips Medical Systems Nederland B.V. Veenpluis 6 Best, NL 5684 Pc |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-18 |
| Decision Date | 2020-04-09 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838080737 | K200713 | 000 |
Trademark Results [EchoNavigator]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ECHONAVIGATOR 79138156 4725742 Live/Registered |
Koninklijke Philips N.V. 2013-10-02 |
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