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

    TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION

    K Number: K982683 · Decision Oct 6, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    31
    Applicant Total
    50
    Review Days
    67

    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
    TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION
    K Number
    K982683
    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
    July 31, 1998
    Decision Date
    October 6, 1998
    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

    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

    HF MEGA EAR

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

    Other Clearances by Telex Communications, Inc.

    K Number Device Name
    K984243 TELEX TINNITUS-COMPANION
    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
    K933095 351-AGCO BEHIND-THE-EAR HEARING AID
    Search all 50 clearances from Telex Communications, Inc. →