Moberg Research, Inc.

FDA Regulatory Profile

Moberg Research, Inc. appears in FDA public data with 1 recall, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1338-2023, Class II) was initiated on February 20, 2023. Its most recent 510(k) clearance was granted on December 17, 2019.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1338-2023Class IIMoberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoriFebruary 20, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K192572CNS EnvisionDecember 17, 2019
K080217COMPONENT NEUROMONITORING SYSTEMNovember 5, 2008