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510(k) Data Aggregation

    K Number
    K022865
    Device Name
    6203
    Date Cleared
    2003-02-13

    (169 days)

    Product Code
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTEMPORARY PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 6203 is indicated for use to conserve oxygen for patients prescribed 1 to 6 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen. The Wave Conserver Model 6203 is indicated for use to conserve oxygen for patients prescribed 1 to 6 liters per minute of supplemental oxygen and use of a nasal cannula and USP bottled oxygen.
    Device Description
    The 6203 with integrated pressure regulator is intended to be used as an accessory to an oxygen supply system to reduce or conserve the amount of oxygen used by the patient. The 6203 is a battery operated electronic device that is microprocessor controlled and contains a breath sensor and a normally closed valve. When installed between the oxygen supply and patient's nasal cannula, the device detects the patient's inhalation, opens the valve according to the flow rate set on the device and delivers a preset bolus of oxygen to the patient as determined by the device flow rate algorithm. The valve closes and conserves the oxygen that would have been wasted during the end of inhalation and during exhalation.
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    K Number
    K992935
    Device Name
    OCD2001
    Date Cleared
    2000-06-20

    (294 days)

    Product Code
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTEMPORARY PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OCD2001 is indicated for use to conserve oxygen for patients prescribed 1/2 to 6 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.
    Device Description
    The OCD2001 is intended to be used as an accessory to an oxygen supply system to reduce or conserve the amount of oxygen used by the patient. The OCD2001 is a battery operated electronic device that is microprocessor controlled and contains a breath sensor and a normally closed valve. When installed between the oxygen supply and patient's nasal cannula, the device detects the patient's inhalation, opens the valve according to the flow rate set on the device and delivers a preset bolus of oxygen to the patient as determined by the device flow rate algorithm. The valve closes and conserves the oxygen that would have been wasted during the end of inhalation and during exhalation.
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    K Number
    K000543
    Device Name
    CONTEMPRO-MIST
    Date Cleared
    2000-06-16

    (119 days)

    Product Code
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTEMPORARY PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K964994
    Device Name
    CPI MODEL 6240 50 PSI NEBULIZER COMPRESSOR
    Date Cleared
    1997-02-21

    (67 days)

    Product Code
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTEMPORARY PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K963558
    Device Name
    CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR
    Date Cleared
    1996-12-04

    (90 days)

    Product Code
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTEMPORARY PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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