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510(k) Data Aggregation

    K Number
    K121587
    Device Name
    BREATH SHAKE
    Manufacturer
    CHEEN HOUNG ENT. CO. LTD.
    Date Cleared
    2013-11-22

    (540 days)

    Product Code
    BYI
    Regulation Number
    868.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHEEN HOUNG ENT. CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K021390
    Device Name
    PMX COMPACT RESUCITATOR
    Manufacturer
    CHEEN HOUNG ENT. CO. LTD.
    Date Cleared
    2002-10-04

    (155 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHEEN HOUNG ENT. CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PMX COMPACT RESUSCITATOR are manual resuscitators incorporating a bag and valve, intended to provide emergency ventilation or ventilation during patient transport. The infant model is intended for patients weighing between 5 to 12 kgs, the child model is intended for patients weighing between 10 to 30 kgs, and the adult model is intended for patients weighing more than 30 kgs approximate weight. The PMX COMPACT RESUSCITATOR provided in reusable models and in the disposable models.
    Device Description
    manual resuscitators incorporating a bag and valve
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    K Number
    K003927
    Device Name
    Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
    Manufacturer
    CHEEN HOUNG ENT. CO. LTD.
    Date Cleared
    2001-06-26

    (188 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHEEN HOUNG ENT. CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010191
    Device Name
    Y2000 POCKET RESCUE
    Manufacturer
    CHEEN HOUNG ENT. CO. LTD.
    Date Cleared
    2001-03-14

    (51 days)

    Product Code
    CBP
    Regulation Number
    868.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHEEN HOUNG ENT. CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K981415
    Device Name
    0-20 CM H20 PEEP VALVE
    Manufacturer
    CHEEN HOUNG ENT. CO. LTD.
    Date Cleared
    1998-07-14

    (85 days)

    Product Code
    BYE
    Regulation Number
    868.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHEEN HOUNG ENT. CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cheen Houng 0-20 Cm H2O PEEP Valve is indicated as an accessory to add positive end expiratory pressure breathing capability to a Manual Resuscitator.
    Device Description
    The Cheen Houng Enterprise Co., Ltd. 0-20 Cm H2O PEEP Valves are similar in intended use, design, material selection, performance and function to Life Design PEEP FLO PEEP Valves which are currently legally and safely marketed in the United States.
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    K Number
    K970688
    Device Name
    POCKET RESCUE
    Manufacturer
    CHEEN HOUNG ENT. CO. LTD.
    Date Cleared
    1997-09-26

    (213 days)

    Product Code
    KGB
    Regulation Number
    868.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHEEN HOUNG ENT. CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cheen Houng Pocket Rescue is indicated for mouth to mask ventilation of a nonbreathing adult.
    Device Description
    Exhaled Air Pulmonary Resuscitators
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