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

    VENTILATOR #1

    K Number: K830488 · Decision Sep 15, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    47
    Review Days
    212

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    Basic Information

    Device Name
    VENTILATOR #1
    K Number
    K830488
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Ohio Medical Products
    Date Received
    February 15, 1983
    Decision Date
    September 15, 1983
    Product Code
    CBK
    Advisory Committee
    Anesthesiology
    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
    CBK Ventilator, Continuous, Facility Use

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    Other Clearances by Ohio Medical Products

    K Number Device Name
    K841733 OHIO WASTE GAS SCAVENGING RESERVOIR
    K842003 OHIO WASTE GAS SCAVENGING INTERFACE
    K840356 OHIO UNITROL II ANESTHESIA GAS MACHINE
    K841274 BAG-TO-VENTILATOR SELECTOR VALVE
    K840967 OHIO HEAT REFLECTING PATCH
    K840858 OHIO 3300 INFANT WARMER SYSTEM
    K840857 OHIO 3000 INFANT WARMER SYSTEM
    K840453 MEDISHIELD PVM RESPIROMETER
    K840452 PREMIUM DABM DISPOS. ANES. BREATH MASK
    K833335 MODULUS II ANESTHESIA GAS MACHINE
    Search all 47 clearances from Ohio Medical Products →