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Grason-Stadler, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K180287GSI CortiMay 11, 2018
K172403GSI NovusOctober 20, 2017
K000097GSI 2000 MIDDLE EAR ANALYZERApril 12, 2000
K974237GSI 70 AUDIOPATH SCREENERFebruary 10, 1998
K970324GSI SA60 DPOAE SYSTEMJune 6, 1997
K953684GSI 61 CLINICAL AUDIOMETEROctober 27, 1995
K951759GSI 65 COMPUTERIZED AUDIOMETERJuly 6, 1995
K902540GSI 17 SCREENING AUDIOMETERJuly 13, 1990
K890124ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETERJuly 14, 1989
K870030THE SCREENER GSI 55 ABR SCREENERMarch 13, 1987
K863353MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)November 3, 1986
K843618AUDIOMETERDecember 3, 1984
K820715MIDDLE EAR ANALYZER (IMPEDANCE AUDIOApril 9, 1982
K810583AUDIOMETERApril 29, 1981
K790846MIDDLE EAR ANALYZER (IMPED. AUDIOMTR)May 17, 1979
K790609AUDIOMETERApril 10, 1979