The following data is part of a premarket notification filed by Philips Medical Systems Dmc Gmbh with the FDA for Proxidiagnost N90.
| Device ID | K173433 |
| 510k Number | K173433 |
| Device Name: | ProxiDiagnost N90 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Philips Medical Systems DMC GmbH Roentgenstrasse 24-26 Hamburg, DE 22335 |
| Contact | Ming Xiao |
| Correspondent | Ming Xiao Philips Medical Systems DMC GmbH Roentgenstrasse 24-26 Hamburg, DE 22335 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-02 |
| Decision Date | 2018-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838085619 | K173433 | 000 |