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 |