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

    PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251

    K Number: K014102 · Decision Feb 21, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    108
    Applicant Total
    15
    Review Days
    70

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    Basic Information

    Device Name
    PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251
    K Number
    K014102
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Atos Medical AB
    Date Received
    December 13, 2001
    Decision Date
    February 21, 2002
    Product Code
    JOH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOH Tube Tracheostomy And Tube Cuff

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    Other Clearances by Atos Medical AB

    K Number Device Name
    K151404 ProTrach Dualcare
    K141380 PROVOX FREEHANDS FLEXIVOICE
    K131947 PROVOX VEGA PUNCTURE SET
    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
    K971244 PROVOX 2 VOICE PROSTHESIS SYSTEM
    K942495 SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM
    Search all 15 clearances from Atos Medical AB →