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

    INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR

    K Number: K872647 · Decision Aug 26, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    21
    Review Days
    50

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    Basic Information

    Device Name
    INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR
    K Number
    K872647
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Int'L Hearing Aids, Inc.
    Date Received
    July 7, 1987
    Decision Date
    August 26, 1987
    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 Int'L Hearing Aids, Inc.

    K Number Device Name
    K873798 INTERNATIONAL MODEL XP BEHIND-THE-EAR
    K873799 INTERNATIONAL MODEL XL BEHIND-THE-EAR
    K873800 INTERNATIONAL MODEL XM BEHIND-THE-EAR
    K864028 MODEL AQ8181 CUSTOM-CANAL-IN-THE EAR HEARING AID
    K864030 MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID
    K864029 AY8182 CUSTOM-SEMI CANAL-IN-THE-EAR HEARING AID
    K864031 MODEL AK 8184 CUSTOM-LOW-PROFILE HEARING AID
    K853942 INT'L MODEL XE BEHIND-THE-EAR HEARING AID
    K853941 INT'L MODEL XG BEHIND-THE-EAR HEARING AID
    K853172 INTERNATIONAL MODEL SC CANAL IN THE EAR HEARING AI
    Search all 21 clearances from Int'L Hearing Aids, Inc. →