The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Echonavigator.
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ECHONAVIGATOR 79138156 4725742 Live/Registered |
Koninklijke Philips N.V. 2013-10-02 |