BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    PROVOX VEGA PUNCTURE SET

    K Number: K131947 · Decision Oct 18, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    39
    Applicant Total
    15
    Review Days
    113

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    Basic Information

    Device Name
    PROVOX VEGA PUNCTURE SET
    K Number
    K131947
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3730
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Atos Medical AB
    Date Received
    June 27, 2013
    Decision Date
    October 18, 2013
    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)

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    Other Clearances by Atos Medical AB

    K Number Device Name
    K151404 ProTrach Dualcare
    K141380 PROVOX FREEHANDS FLEXIVOICE
    K092593 PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)
    K090455 PROVOX VEGA, MODEL 8130-8135
    K072582 PROVOX MICRON HME
    K043138 PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134
    K022125 PROVOX FREEHANDS HME, MODEL 7710
    K014102 PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251
    K971244 PROVOX 2 VOICE PROSTHESIS SYSTEM
    K942495 SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM
    Search all 15 clearances from Atos Medical AB →