Phonic Ear, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
31
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K043090EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMSDecember 23, 2004
K974658INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSETFebruary 25, 1998
K974287FM RECEIVER - AUDITORY TRAINERFebruary 10, 1998
K950730GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)June 30, 1995
K940313PHONIC EARMarch 22, 1994
K923234PE 400IR, PE 400T, PE 400ESeptember 29, 1992
K922720GROUP AUDITORY TRAINING SYSTEMAugust 24, 1992
K912356GROUP AUDITORY TRAINER,FM RECEIVERAugust 15, 1991
K893431AUDITORY TRAINER PE150R FM RECEIVERAugust 21, 1989
K882409PE100R FM RECEIVER USED W/PE100T FM TRANSMITTERJuly 5, 1988
K881099PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTERJune 7, 1988
K874304PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCLNovember 20, 1987
K872473POST-AURICULAR HEARING AID MODEL PE 805CD2July 28, 1987
K872474POST-AURICULAR HEARING AID MODEL PE 805 SCD2July 28, 1987
K864672PHONIC EAR MODELS PE 811CS AND PE 811CSTFebruary 20, 1987
K862773PHONIC EAR, MODEL PE475ROctober 9, 1986
K862229PHONIC EAR PE 602 PPCSJuly 22, 1986
K862162PHONIC EAR, MODEL PE 1800July 18, 1986
K861857PHONIC EARJune 9, 1986
K844862POST-AURICULAR HEARING AID MODEL PE 600PPCHApril 8, 1985