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510(k) Data Aggregation

    K Number
    K083351
    Device Name
    PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P
    Manufacturer
    COMDEK INDUSTRIAL CORP.
    Date Cleared
    2009-04-24

    (162 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMDEK INDUSTRIAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The COMDEK Portable Pulse Oximeter MD-600P offers non-invasive continuous and instantaneous monitoring, and provides users with high-level accuracy and a quick measuring response. The environments for use are hospitals, intra-hospital transport, hospital-type facilities and the home. The device is intended for use only with adults.
    Device Description
    Not Found
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