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

    MODIFICATION TO MARSPO2, MODEL 2001

    K Number: K000794 · Decision Apr 10, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    45
    Review Days
    28

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    Basic Information

    Device Name
    MODIFICATION TO MARSPO2, MODEL 2001
    K Number
    K000794
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Novametrix Medical Systems, Inc.
    Date Received
    March 13, 2000
    Decision Date
    April 10, 2000
    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
    K010451 NOVAMETRIX MARQUETTE COMPATIBLE SENSORS
    K993979 MARSPO2, MODEL 2001
    K982499 COSMO PLUS WITH NICO, MODEL 8200
    K964360 VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101
    K963380 CO 2 SMO PLUS
    K963327 TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610
    K960831 VENTRAK RMMS 1550
    K924626 NOVAMETRIX MODEL 510
    K920379 NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX
    K913516 MODEL 520A NOVAMETRIX PULSE OXIMETER
    Search all 45 clearances from Novametrix Medical Systems, Inc. →