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

    CRYOPETTE

    K Number: K100596 · Decision Dec 6, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    49
    Applicant Total
    4
    Review Days
    279

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    Basic Information

    Device Name
    CRYOPETTE
    K Number
    K100596
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mid-Atlantic Diagnostics, Inc.
    Date Received
    March 2, 2010
    Decision Date
    December 6, 2010
    Product Code
    MQK
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MQK Labware, Assisted Reproduction

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    Other Clearances by Mid-Atlantic Diagnostics, Inc.

    K Number Device Name
    K041435 THE STRIPPER PGD
    K030525 CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES
    K993699 THE STRIPPER