The following data is part of a premarket notification filed by Philips Healthcare with the FDA for Percunav.
Device ID | K121498 |
510k Number | K121498 |
Device Name: | PERCUNAV |
Classification | System, X-ray, Tomography, Computed |
Applicant | PHILIPS HEALTHCARE 49 SPADINA AVENUE #310 Toronto, CA M5v 2j1 |
Contact | Tara Mackinnon |
Correspondent | Tara Mackinnon PHILIPS HEALTHCARE 49 SPADINA AVENUE #310 Toronto, CA M5v 2j1 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-05-21 |
Decision Date | 2012-12-14 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PERCUNAV 77106674 5570797 Live/Registered |
PHILIPS ELECTRONICS LTD PHILIPS ELECTRONIQUE LTEE 2007-02-13 |