Device Listing 1809410908

Listing Summary#

Listing key
1809410908
Premarket submission
K152321
Device
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
Decision date
2015-12-04