PDE-NEO
System, X-ray, Angiographic
HAMAMATSU PHOTONICS, K.K.
The following data is part of a premarket notification filed by Hamamatsu Photonics, K.k. with the FDA for Pde-neo.
Pre-market Notification Details
| Device ID | K133719 |
| 510k Number | K133719 |
| Device Name: | PDE-NEO |
| Classification | System, X-ray, Angiographic |
| Applicant | HAMAMATSU PHOTONICS, K.K. 700 13TH STREET, NW SUITE 1200 Washington, DC 20005 |
| Contact | Jeffrey K Shapiro |
| Correspondent | Jeffrey K Shapiro HAMAMATSU PHOTONICS, K.K. 700 13TH STREET, NW SUITE 1200 Washington, DC 20005 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2013-12-05 |
| Decision Date | 2014-03-27 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04582389010543 | K133719 | 000 |
| 04582389010093 | K133719 | 000 |
| 04582389010871 | K133719 | 000 |
Trademark Results [PDE-NEO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PDE-NEO 85711737 4641678 Live/Registered |
Hamamatsu Photonics K.K. 2012-08-23 |
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