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

    PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER

    K Number: K881099 · Decision Jun 7, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    31
    Applicant Total
    31
    Review Days
    84

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    Basic Information

    Device Name
    PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER
    K Number
    K881099
    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
    March 15, 1988
    Decision Date
    June 7, 1988
    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

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    Other Clearances by Phonic Ear, Inc.

    K Number Device Name
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    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
    K893431 AUDITORY TRAINER PE150R FM RECEIVER
    K882409 PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER
    Search all 31 clearances from Phonic Ear, Inc. →