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

    NOVAMETRIX MODEL 505 PULSE OXIMETER

    K Number: K873078 · Decision Sep 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    45
    Review Days
    49

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    Basic Information

    Device Name
    NOVAMETRIX MODEL 505 PULSE OXIMETER
    K Number
    K873078
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Novametrix Medical Systems, Inc.
    Date Received
    August 5, 1987
    Decision Date
    September 23, 1987
    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 Novametrix Medical Systems, Inc.

    K Number Device Name
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    K982499 COSMO PLUS WITH NICO, MODEL 8200
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    K963380 CO 2 SMO PLUS
    K963327 TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610
    K960831 VENTRAK RMMS 1550
    K924626 NOVAMETRIX MODEL 510
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