Compumedics Limited

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252383Somfit DAugust 28, 2025
K242447Falcon HSTFebruary 20, 2025
K231546SomfitNovember 30, 2023
K230073OktiFebruary 9, 2023
K191785Orion LifeSpan MEGFebruary 14, 2020
K093223COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECGJanuary 15, 2010
K072201COMPUMEDICS SOMTE PSG RECORDING SYSTEMApril 14, 2008
K021176COMPUMEDICS SOMTE SYSTEMJanuary 21, 2003
K003175COMPUMEDICS SIESTA SYSTEMDecember 27, 2000