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

    SENSOR TAPE CAT. NO. ST-45

    K Number: K852407 · Decision Oct 21, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    16
    Applicant Total
    20
    Review Days
    137

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    Basic Information

    Device Name
    SENSOR TAPE CAT. NO. ST-45
    K Number
    K852407
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    American Omni Medical, Inc.
    Date Received
    June 6, 1985
    Decision Date
    October 21, 1985
    Product Code
    DTW
    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
    DTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

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    Other Clearances by American Omni Medical, Inc.

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    K884893 CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25
    K884640 CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700
    K873316 BUBBLE TRAP-FILTER CAT. NO B180F37
    K875080 AIR VENT LINE CAT. NO. AVL-36
    K873802 PRESSURE BARRIER KIT CAT. NO. PBK-3
    K873610 PEDIATRIC BUBBLE TRAP CAT. NO. B-100
    K873488 SILENT GUARD CAT. NO. SG-10
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