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 |