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

    TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER

    K Number: K915384 · Decision Jan 17, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    31
    Applicant Total
    50
    Review Days
    49

    Basic Information

    Device Name
    TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER
    K Number
    K915384
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3320
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Telex Communications, Inc.
    Date Received
    November 29, 1991
    Decision Date
    January 17, 1992
    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 Telex Communications, Inc.

    K Number Device Name
    K984243 TELEX TINNITUS-COMPANION
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    K964639 TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II
    K963915 TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION
    K961143 TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40
    K954579 TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION
    K943961 THE MODEL ACAPPELLA IN THE EAR HEARING AID
    K935048 ARTISAN PROGRAMMER & HEARING AID
    K935366 BINAURAL HEARING AID
    K933579 MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID
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