The following data is part of a premarket notification filed by Ziehm Imaging Gmbh with the FDA for Ziehm 8000.
| Device ID | K190497 |
| 510k Number | K190497 |
| Device Name: | Ziehm 8000 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Ziehm Imaging GmbH Donaustrasse 31 Nuremberg, DE 90451 |
| Contact | Steve Seeman |
| Correspondent | Steve Seeman Ziehm Imaging, Inc. 6280 Hazeltine National Drive Orlando, FL 32822 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-28 |
| Decision Date | 2019-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EZIEZIEHM8000 | K190497 | 000 |
| EZIEZIEHM80001 | K190497 | 000 |