Phonic Ear, Inc.

FDA Regulatory Profile

Phonic Ear, Inc. appears in FDA public data with 0 recalls, 31 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Dec 23, 2004.

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 SYSTEMSDec 23, 2004
K974658INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSETFeb 25, 1998
K974287FM RECEIVER - AUDITORY TRAINERFeb 10, 1998
K950730GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)Jun 30, 1995
K940313PHONIC EARMar 22, 1994
K923234PE 400IR, PE 400T, PE 400ESep 29, 1992
K922720GROUP AUDITORY TRAINING SYSTEMAug 24, 1992
K912356GROUP AUDITORY TRAINER,FM RECEIVERAug 15, 1991
K893431AUDITORY TRAINER PE150R FM RECEIVERAug 21, 1989
K882409PE100R FM RECEIVER USED W/PE100T FM TRANSMITTERJul 5, 1988
K881099PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTERJun 7, 1988
K874304PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCLNov 20, 1987
K872473POST-AURICULAR HEARING AID MODEL PE 805CD2Jul 28, 1987
K872474POST-AURICULAR HEARING AID MODEL PE 805 SCD2Jul 28, 1987
K864672PHONIC EAR MODELS PE 811CS AND PE 811CSTFeb 20, 1987
K862773PHONIC EAR, MODEL PE475ROct 9, 1986
K862229PHONIC EAR PE 602 PPCSJul 22, 1986
K862162PHONIC EAR, MODEL PE 1800Jul 18, 1986
K861857PHONIC EARJun 9, 1986
K844862POST-AURICULAR HEARING AID MODEL PE 600PPCHApr 8, 1985