The following data is part of a premarket notification filed by Philips Medical Systems Dmc Gmbh with the FDA for Combidiagnost R90.
| Device ID | K203087 |
| 510k Number | K203087 |
| Device Name: | CombiDiagnost R90 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | Philips Medical Systems DMC GmbH Roentgenstrasse 24-26 Hamburg, DE 22335 |
| Contact | Supriya Dalvi |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | JAA |
| Subsequent Product Code | KPR |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-10-13 |
| Decision Date | 2020-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838101456 | K203087 | 000 |