The following data is part of a premarket notification filed by Zetta Medical Technologies, Llc. with the FDA for Z-dose29.
| Device ID | K170273 |
| 510k Number | K170273 |
| Device Name: | Z-DOSE29 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | ZETTA MEDICAL TECHNOLOGIES, LLC. 1313 ENSELL ROAD Lake Zurich, IL 60047 |
| Contact | Main M. Ghazal |
| Correspondent | Main M. Ghazal ZETTA MEDICAL TECHNOLOGIES, LLC. 1313 ENSELL ROAD Lake Zurich, IL 60047 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-30 |
| Decision Date | 2017-04-28 |
| Summary: | summary |