BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BLAISE-RATHAEL VOICE PROSTHESIS

    K Number: K832852 · Decision Sep 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    39
    Applicant Total
    71
    Review Days
    44

    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
    BLAISE-RATHAEL VOICE PROSTHESIS
    K Number
    K832852
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3730
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Richards Medical Co., Inc.
    Date Received
    August 16, 1983
    Decision Date
    September 29, 1983
    Product Code
    EWL
    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
    EWL Prosthesis, Laryngeal (Taub)

    Similar 510(k) Clearances

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

    FirstFit Surgical Kit

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PROVOX FREEHANDS FLEXIVOICE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PROVOX VEGA PUNCTURE SET

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    BLOM-SINGER INDWELLING TEP OCCLUDER

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PROVOX VEGA, MODEL 8130-8135

    FDA 510(k)
    FDA Class 2 ·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. →