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

    THE VISUAL SPEECH AID

    K Number: K781522 · Decision Nov 8, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    64

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    Basic Information

    Device Name
    THE VISUAL SPEECH AID
    K Number
    K781522
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Exeter Medical Labs, Inc.
    Date Received
    September 5, 1978
    Decision Date
    November 8, 1978
    Product Code
    LFA
    Advisory Committee
    Unknown
    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
    LFA Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)

    Similar 510(k) Clearances

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

    EXETER LIP SEAL

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Exeter Medical Labs, Inc.

    K Number Device Name
    K790554 EXETER LIP SEAL