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Etymotic Research

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K150491ER36 Series OAE Test SystemMarch 26, 2015
K112733ER35 ERO-SCAN PRO HEARING TEST SYSTEMDecember 16, 2011
K070880ER35 ERO-SCAN PRO HEARING TEST SYSTEMJune 7, 2007
K011114ETYMOTIC RESEARCH ER-10D OAE PROBEJuly 3, 2001
K010165ERO SCAN OAE TEST SYSTEMMarch 12, 2001
K980533ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)March 23, 1998
K930553CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENTSeptember 29, 1993
K930003TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONESJune 18, 1993
K873298ELEC-TIPNovember 24, 1987
K861113ER-7C CLINICAL PROBE MICROPHONEApril 23, 1986
K843144K-BASS LO FREQUENCY HEARING AIDSeptember 7, 1984