BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AUDITORY TRAINER PE150R FM RECEIVER

    K Number: K893431 · Decision Aug 21, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    31
    Applicant Total
    31
    Review Days
    111

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    AUDITORY TRAINER PE150R FM RECEIVER
    K Number
    K893431
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3320
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Phonic Ear, Inc.
    Date Received
    May 2, 1989
    Decision Date
    August 21, 1989
    Product Code
    EPF
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EPF Hearing Aid, Group And Auditory Trainer

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EPF), ordered by most recent decision date.

    HYPERSOUND AUDIO SYSTEM (HSS)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    FM RECEIVER - AUDITORY TRAINER

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    WILLIAMS SOUND, PERSONAL FM, HEARING HELPER

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    WILLIAMS SOUND, PERSONAL FM, HEARING HELPER

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by Phonic Ear, Inc.

    K Number Device Name
    K043090 EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS
    K974658 INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT
    K974287 FM RECEIVER - AUDITORY TRAINER
    K950730 GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)
    K940313 PHONIC EAR
    K923234 PE 400IR, PE 400T, PE 400E
    K922720 GROUP AUDITORY TRAINING SYSTEM
    K912356 GROUP AUDITORY TRAINER,FM RECEIVER
    K882409 PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER
    K881099 PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER
    Search all 31 clearances from Phonic Ear, Inc. →