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

    AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX

    K Number: K103527 · Decision Apr 15, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    24
    Applicant Total
    6
    Review Days
    135

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    Basic Information

    Device Name
    AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
    K Number
    K103527
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5410
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    International Biomedical, Ltd.
    Date Received
    December 1, 2010
    Decision Date
    April 15, 2011
    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 International Biomedical, Ltd.

    K Number Device Name
    K103525 A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX
    K103523 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
    K103524 VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
    K093260 AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM
    K081399 AVIATOR TRANSPORT INCUBATOR