General Hearing Instruments, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K061459TRANQUIL TRI-BTEJune 30, 2006
K974751TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CICMarch 6, 1998
K971399AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CICJune 13, 1997
K943144AURIS CICJuly 20, 1994
K850123IN-TH-EAR HEARING AIDMarch 21, 1985