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

    ATOM TRANSCAPSULE V-707

    K Number: K123937 · Decision May 23, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    24
    Applicant Total
    10
    Review Days
    154

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    Basic Information

    Device Name
    ATOM TRANSCAPSULE V-707
    K Number
    K123937
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5410
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Atom Medical Corporation
    Date Received
    December 20, 2012
    Decision Date
    May 23, 2013
    Product Code
    FPL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FPL Incubator, Neonatal Transport

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    Other Clearances by Atom Medical Corporation

    K Number Device Name
    K120937 SUNFLOWER WARNER
    K111547 BILI-THERAPY PAD TYPE
    K103317 RESUSCITATION UNIT 105
    K102542 RESUSCI FLOW; RESUSCI FLOW 104
    K103828 BILI-THERAPY SPOT TYPE
    K102227 INFA WARMER I
    K102226 DUAL INCU I
    K102279 INCU I
    K102710 NEO-SERVO I