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

    U-IMPULSE AIR CONDUCTION IN-THE-CANAL HEARING AID

    K Number: K873560 · Decision Sep 29, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    71
    Review Days
    27

    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
    U-IMPULSE AIR CONDUCTION IN-THE-CANAL HEARING AID
    K Number
    K873560
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Richards Medical Co., Inc.
    Date Received
    September 2, 1987
    Decision Date
    September 29, 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

    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 Richards Medical Co., Inc.

    K Number Device Name
    K896106 ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS
    K900628 MODULAR HIP SYSTEM
    K896580 UNI-POLAR HEAD
    K895241 INTRAMEDULLARY HIP SCREW
    K884824 TRICON-M TOTAL KNEE SYSTEM
    K896204 ZIRCONIA CERAMIC HEAD ADD'L SIZES
    K895242 PAPPAS TRI-FLANGE VENTILATION TUBE
    K893377 RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS
    K885069 ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)
    K892366 POROUS GENESIS STEMMED TIBIAL COMPONENT
    Search all 71 clearances from Richards Medical Co., Inc. →