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

    PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR

    K Number: K892886 · Decision Oct 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    11
    Review Days
    191

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    Basic Information

    Device Name
    PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR
    K Number
    K892886
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Percussionaire Corp.
    Date Received
    April 19, 1989
    Decision Date
    October 27, 1989
    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 Percussionaire Corp.

    K Number Device Name
    K905234 TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES
    K905235 VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS
    K905236 IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES
    K900315 PERCUSSIONAIRE TXP TRANSPORTER/RESPIRATORS 750 MIN
    K900314 PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN
    K900313 PERCUSSIONAIRE(R) VDR-3 IMV PERCUS/RESPIR 1250 MIN
    K896586 RATE INCREASE FOR IPPB/IPV
    K895485 BIRD (IPV) NONCONTINUOUS VENTILATORS
    K895486 BIRD (VDR) SINUSOIDAL PERCUSSIONATORS
    K884832 PERCUSSIONAIRE RESPIRATORS (MULTIPLE)
    Search all 11 clearances from Percussionaire Corp. →