Qfix · Class II · Cleared Dec 4, 2015
| K-number | K152321 |
| Device name | kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening |
| Applicant | Qfix |
| Product code | IYE |
| Device class | Class II |
| Decision date | Dec 4, 2015 |
| 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