The following data is part of a premarket notification filed by Philips Medical Systems Dmc Gmbh with the FDA for Philips Combidiagnost R90.
| Device ID | K163210 |
| 510k Number | K163210 |
| Device Name: | Philips CombiDiagnost R90 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| 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 | JAA |
| Subsequent Product Code | KPR |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-15 |
| Decision Date | 2017-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838076747 | K163210 | 000 |