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510(k) Data Aggregation

    K Number
    K110293
    Device Name
    OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER
    Manufacturer
    RESPIRONICS NEW JERSEY, INC.
    Date Cleared
    2011-08-09

    (189 days)

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

    RESPIRONICS NEW JERSEY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OptiChamber Diamond Valved Holding Chamber device is intended to be used by patients who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. The intended environments for use include the home, hospitals and clinics. For Single Patient Use . Recommended Patient Population: OptiChamber Diamond: Age 5 and up OptiChamber Diamond with Small LiteTouch mask: 0 to 18 months OptiChamber Diamond with Medium LiteTouch mask: 1 to 5 years OptiChamber Diamond with Large LiteTouch mask: 5 years +
    Device Description
    The OptiChamber Diamond Valved Holding Chamber (VHC) is a Class II device. It is intended to be used in combination with most pressurized Metered Dose Inhalers (pMDIs) to assist in respiratory drug delivery. The OptiChamber Diamond Valved Holding Chamber is a device utilizing the same operating principles as the AeroChamber Plus Z-Stat Valved Holding Chamber (K052332). Both the AeroChamber Plus Z-Stat and the OptiChamber Diamond are available with and without mask. The valved holding chamber (VHC) is designed to assist patients who cannot correctly coordinate actuation of the pressurized metered dose inhaler (pMDIs) with inhalation. The VHC works by 'holding' the aerosol cloud emitted from the pMDI inside the chamber so that the larger aerosol particles are removed from the aerosol cloud by impaction into the chamber walls and sedimentation under the influence of gravity. The OptiChamber Diamond Valved Holding Chamber is made of antistatic plastic materials alleviating any need to wash prior to first use. OptiChamber Diamond is comprised of: the mouthpiece, the chamber, the adapter (end cap) with inhalation flow alert, the exhaust valve, the inhalation valve, the valve retaining ring, and the cap.
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    K Number
    K100285
    Device Name
    LITETOUCH MASK
    Manufacturer
    RESPIRONICS NEW JERSEY, INC.
    Date Cleared
    2010-06-29

    (148 days)

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

    RESPIRONICS NEW JERSEY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LiteTouch medium mask for ages 1-5 is to be used with OptiChamber Advantage Valved Holding Chambers. The mask is intended to be used to help administer aerosolized medication from most pressurized metered dose inhalers used with valved holding chambers as prescribed by a physician or health care professional. The intended environments for use include homes, hospitals, and clinics.
    Device Description
    The LiteTouch mask is a Class II device. It is a mask for use with Respironics' OptiChamber Valved Holding Chamber (K962822). The LiteTouch mask is a mask that utilizes the same operating principles as the AeroChamber Max Valved Holding Chamber Small and Medium Mask (K032972). The difference between the LiteTouch mask and the AeroChamber Max Valved Holding Chamber Small and Medium Mask is that, the LiteTouch mask does not come assembled to the chamber and the exhalation valve is located in different positions and is not of the same shape. The LiteTouch mask comprises of a Flap Valve and a Cushion plate.
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    K Number
    K072418
    Device Name
    OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER
    Manufacturer
    RESPIRONICS NEW JERSEY, INC.
    Date Cleared
    2007-09-12

    (15 days)

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

    RESPIRONICS NEW JERSEY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OptiChamber Advantage Anti-Static Valved Holding Chamber is intended to be used in combination with Metered Dose Inhalers (MDIs) for respiratory drug delivery. This device, as is the case with other spacer devices, is intended to leave larger non-respirable drug particles within the device and allows smaller respirable particles to be delivered to the lungs.
    Device Description
    OptiChamber Advantage Anti-Static (OCAS) is a Class II device. It is a valved holding chamber for use with metered dose inhalers (MDIs). The OCAS is a valved holding chamber utilizing the same operating principles as the OptiChamber (K962822) and the AeroChamber Z-Stat (K052322). The difference between the OCAS and the OptiChamber is that, like the AeroChamber Z-Stat, the OCAS is made of an anti-static plastic material. OptiChamber Advantage Anti-Static Valved Holding Chamber has a chamber and mouthpiece made of anti-static material. Non-anti-static valved holding chambers must be washed prior to use. The use of anti-static material in the aerosol path allows an unwashed device to produce the same drug delivery as a washed device.
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    K Number
    K053203
    Device Name
    MYNEB NEBULIZER, MODEL RDD100
    Manufacturer
    RESPIRONICS NEW JERSEY, INC.
    Date Cleared
    2005-12-20

    (34 days)

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

    RESPIRONICS NEW JERSEY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MyNeb is an AC or battery-pack powered nebulizer designed to convert liquid medication into aerosol for inhalation by the patient.
    Device Description
    This AC (adaptor with DC converter) or battery-pack powered nebulizer is housed in a plastic case. Dimensions are 4.96"(II) x 2.80° (V) x 1.46"(I) x 1.46"(I) and weighs 4 ounces. It consists of a piezoelectric element driven by a microprocessor with dedicated software. The batteries are rechargeable via an AC power supply (100-240 VAC, 50-60 Hz). The external battery pack is made up of 2 lithium polymer cells. The following is the method of acrosol generation: Step 1: Ultrasonic energy is created and focused by a concave piezoelectric element, located within the generator, to a point at the base of the medication chamber that is located at the top of the generator. Step 2: The focused ultrasonic energy forms a liquid fountain that is driven up through the guide tube inside the nebulizer head. Upon exiting the tube, the energized liquid fountain generates cavitation of acrosol particles and the liquid medication is converted into an aerosol. Step 3: The forces associated with the fountain generate an air draft whereby air is drawn into the nebulizer head via the air vents. The aerosolized medicine is carried by this air draft, through the nebulizer's chimney and out through the nebulizer's mouthpiece opening. Step 4: Non aerosolized liquid medication returns back into the medication chamber for re-generation through the guide tube.
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    K Number
    K042655
    Device Name
    INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456
    Manufacturer
    RESPIRONICS NEW JERSEY, INC.
    Date Cleared
    2004-10-13

    (15 days)

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

    RESPIRONICS NEW JERSEY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This nebulizer compressor is an AC-powered air compressor nebulizer system intended to provide a source of compressed air for medical purposed for use in home health care. It is to be used with a pneumatic nebulizer to produce aerosol particles of medication for respiratory therapy for both children and adults.
    Device Description
    This line-powered piston compressor is housed in a plastic cabinet (case). Dimensions are 7.5" (L) x 7.49" (W) x 4.18" (H) and weighs 3.3 lbs. It consists of a motor-driven piston compressor and a switch; it contains no consists of a noter electronic components. It operates from 115 VAC, 60 Hz. It is supplied with tubing, an instruction manual, and a Sidestream (510(k) cleared) nebulizer. The Inspiration Elite, Model HS456 is not be used without the nebulizer. In use, the compressor is placed on a flat surface and the nebulizer tubing is connected to the hose barb. The unit is then turned on. Inlet air to the compressor passes through a replaceable filter.
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