BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    POST-AURICULAR HEARING AID (#PE830)

    K Number: K810030 · Decision Jan 14, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    1366
    Applicant Total
    10
    Review Days
    8

    Basic Information

    Device Name
    POST-AURICULAR HEARING AID (#PE830)
    K Number
    K810030
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    HC ELECTRONICS
    Date Received
    January 6, 1981
    Decision Date
    January 14, 1981
    Product Code
    ESD
    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
    ESD Hearing Aid, Air-Conduction, Prescription

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    Other Clearances by HC ELECTRONICS

    K Number Device Name
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    K782053 HEARING AID, POST-AURICULAR
    K780936 PHONIC EAR
    K780363 PHONIC EAR
    K772347 PHONIC MIRROR HANDIVOICE MODEL 120
    K772346 PHONIC MIRROR HANDIVOCIE MODEL 110
    K771357 GROUP AUDITORY TRAINER HC 431R
    K771356 POST-AURICULAR HEARING AID HC 880