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

    SENSILASE PAD 3000

    K Number: K040654 · Decision Jun 4, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    136
    Applicant Total
    7
    Review Days
    84

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    Basic Information

    Device Name
    SENSILASE PAD 3000
    K Number
    K040654
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.2100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Optical Sensors, Inc.
    Date Received
    March 12, 2004
    Decision Date
    June 4, 2004
    Product Code
    DPW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DPW Flowmeter, Blood, Cardiovascular

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    Other Clearances by Optical Sensors, Inc.

    K Number Device Name
    K010795 CAPNOPROBE SL, MODEL 2000
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    K963935 OLYMPUS CRITICAL CARE MONITORING SYSTEM
    K951094 POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM
    K931185 SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE