Zdi, Solutions, LLC · Class II · Cleared Nov 1, 2016
| K-number | K162002 |
| Device name | Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay |
| Applicant | Zdi, Solutions, LLC |
| Product code | IYE |
| Device class | Class II |
| Decision date | Nov 1, 2016 |
| Decision | Substantially Equivalent |
| Regulation | 892.5050 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov