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Telex Communications, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
50
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K984243TELEX TINNITUS-COMPANIONJanuary 21, 1999
K982683TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSIONOctober 6, 1998
K964639TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-IIJanuary 21, 1997
K963915TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSIONNovember 8, 1996
K961143TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40May 7, 1996
K954579TELEX 349 MULTI CROS W/ADAPIVE COMPRESSIONDecember 8, 1995
K943961THE MODEL ACAPPELLA IN THE EAR HEARING AIDMay 15, 1995
K935048ARTISAN PROGRAMMER & HEARING AIDFebruary 9, 1994
K935366BINAURAL HEARING AIDJanuary 13, 1994
K933579MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AIDAugust 23, 1993
K933095351-AGCO BEHIND-THE-EAR HEARING AIDJuly 26, 1993
K931134BEHIND-THE-EAR HEARING AID, TELEX MODEL 361-PPApril 14, 1993
K931157BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PPApril 14, 1993
K931158MEMOREX MODEL 361-AGCO HEARING AIDApril 14, 1993
K922065TELEX MODEL M29 ITE CUSTOM HEARING AIDMay 18, 1992
K922066TELEX MODEL 28A ITE CUSTOM HEARING AIDMay 18, 1992
K915384TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVERJanuary 17, 1992
K915398TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVERJanuary 17, 1992
K915383TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVERJanuary 17, 1992
K915397TDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVERJanuary 17, 1992