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Elekon Industries U.S.A., Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K042705DISPOSABLE NON-ADHESIVE SPO2 SENSORSDecember 29, 2004
K042675FLEXI-STAT SP02 EAR SENSORDecember 6, 2004
K042704REUSABLE FINGER CLIP SPO2 SENSORSNovember 26, 2004
K041522FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORSSeptember 14, 2004
K041647FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLSeptember 2, 2004
K041644FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPJuly 29, 2004