BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SPECTRUM CO-OXIMETER LINEARITY CONTROL

    K Number: K945860 · Decision Jan 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    66
    Applicant Total
    21
    Review Days
    47

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    Basic Information

    Device Name
    SPECTRUM CO-OXIMETER LINEARITY CONTROL
    K Number
    K945860
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Phoenix Diagnostics, Inc.
    Date Received
    December 1, 1994
    Decision Date
    January 17, 1995
    Product Code
    JJS
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JJS Controls For Blood-Gases, (Assayed And Unassayed)

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    Other Clearances by Phoenix Diagnostics, Inc.

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    K020148 pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
    K020129 PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE
    K013451 PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
    K012987 PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER
    K012509 PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM
    K960592 ELECTROLYTE STANDARDS
    K920285 BLOOD GAS/ISE LINEARITY CONTROL
    K912718 ENZYME LINEARITY CONTROL
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