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

    IM2001 PULSE OXIMETER

    K Number: K012706 · Decision Mar 7, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    7
    Review Days
    570

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    Basic Information

    Device Name
    IM2001 PULSE OXIMETER
    K Number
    K012706
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imagyn Medical Technologies, Inc.
    Date Received
    August 14, 2001
    Decision Date
    March 7, 2003
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    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
    DQA Oximeter

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    Other Clearances by Imagyn Medical Technologies, Inc.

    K Number Device Name
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    K991526 ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501
    K980096 OAC (OPTICAL ASPIRATING CURETTE)
    K980291 IMPOWER EXTERNAL VACUUM SYSTEM
    K974173 ERECAID SYSTEM/STAY EREC SYSTEM