The following data is part of a premarket notification filed by Ziehm Imaging Gmbh with the FDA for Ziehm Solo Fd.
| Device ID | K161976 |
| 510k Number | K161976 |
| Device Name: | Ziehm Solo FD |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | ZIEHM IMAGING GMBH DONAUSTRASSE 31 Nuremberg, DE D-90451 |
| Contact | Richard L. Westrich |
| Correspondent | Richard L. Westrich 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 | 2016-07-18 |
| Decision Date | 2016-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EZIEZIEHMSOLOFD1 | K161976 | 000 |