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

    WIDEX MODEL D32

    K Number: K922708 · Decision Jun 30, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    52
    Review Days
    25

    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
    WIDEX MODEL D32
    K Number
    K922708
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Widex Hearing Aid Co., Inc.
    Date Received
    June 5, 1992
    Decision Date
    June 30, 1992
    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

    Similar 510(k) Clearances

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

    Lyric4 Hearing Aid

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    LYRIC2

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    LYRIC HEARING AID

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    INSOUND XT SERIES HEARING AID

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat
    View all

    Other Clearances by Widex Hearing Aid Co., Inc.

    K Number Device Name
    K080955 ZEN PROGRAM (MIND 440 HEARING AID)
    K971535 WIDEX SENSO DIGITAL (MINI CANAL)
    K970904 WIDEX SENSO DIGITAL (CIC)
    K965254 WIDEX MODEL SENSO DIGITAL (C9)
    K965218 SENSO DIGITAL (C18)
    K955879 WIDEX MODEL SENSO DIGITAL (C16)
    K955878 WIDEX MODEL SENSO DIGITAL (C8)
    K954526 WIDEX SENSO DIGITAL (PX)
    K952229 WIDEX MODEL LOGO 32 (L32)
    K946071 LX-ITC
    Search all 52 clearances from Widex Hearing Aid Co., Inc. →