The following data is part of a premarket notification filed by Philips Medical Systems Dmc Gmbh with the FDA for Proxidiagnost N90.
| Device ID | K212837 |
| 510k Number | K212837 |
| Device Name: | ProxiDiagnost N90 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | Philips Medical Systems DMC GmbH Roentgenstrasse 24-26 Hamburg, DE 22335 |
| Contact | Supriya Dalvi |
| Correspondent | Supriya Dalvi Philips Medical Systems DMC GmbH Roentgenstrasse 24-26 Hamburg, DE 22335 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-07 |
| Decision Date | 2021-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838103221 | K212837 | 000 |
| 00884838110588 | K212837 | 000 |