The following data is part of a premarket notification filed by Ziehm Imaging Gmbh with the FDA for Ziehm Vision Rfd.
| Device ID | K132904 |
| 510k Number | K132904 |
| Device Name: | ZIEHM VISION RFD |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | ZIEHM IMAGING GMBH 6280 HAZELTINE NATIONAL DR. Orlando, FL 32822 |
| Contact | Richard L Westrich |
| Correspondent | Richard L Westrich ZIEHM IMAGING GMBH 6280 HAZELTINE NATIONAL DR. Orlando, FL 32822 |
| Product Code | JAA |
| Subsequent Product Code | OWB |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-16 |
| Decision Date | 2013-12-05 |
| Summary: | summary |