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510(k) Data Aggregation

    K Number
    K040576
    Device Name
    MICROMESAM BASIC-SET
    Manufacturer
    MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH
    Date Cleared
    2004-07-01

    (119 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The microMESAM® Basic-Set is used for recording the patient's respiratory nasal pressure during sleep. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's test score.
    Device Description
    The MicroMESAM® Basic-Set consists of a reusable microMESAM® recorder, disposable nasal pressure cannula and patient's instruction manuals, microMESAM® installation CD, system instruction manual for specialist medical personnel, batteries, reusable belt for attaching the microMESAM® recorder, USB cable, carrying bag, and Luer-lock caps. The microMESAM® recorder is a single channel battery-powered respiratory pressure sensor system and provides recordings of respiratory pressure during sleep. The physician prescribed device will help to recognise sleep-related respiratory disorders and lead to comprehensive clinical diagnosis and therapy. The patient may actually perform the recording at home by himself. The microMESAM® recorder must be fastened with the reusable belt on the patient's chest. All relevant respiratory information during sleep will be collected via nasal pressure cannula. The disposable plastic nasal pressure cannula is connected to the microMESAM® recorder and fixed at the patient's nose. After recording, the microMESAM® recorder must be returned to the physician. With the microMESAM® software installed on a personnel computer the physician has the possibility to generate a report with the recorded and analysed data.
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    K Number
    K023068
    Device Name
    PAPILLON MASK SET
    Manufacturer
    MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH
    Date Cleared
    2003-05-28

    (254 days)

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

    MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Papillon® Mask Set is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure), operating at or above 4 cm H,O for the treatment of adult obstructive sleep apnea. The mask is single patient reusable.
    Device Description
    The Papillon® Mask Set is a patient interface accessory for use with nasal Continuous Positive Airway Pressure (CPAP) and bi-level systems used in the treatment of Obstructive Sleep Apnea (OSA). One mask set consists of a mask cushion, forehead pad, mask frame, hose connector system and the AeroFix headgear with the AeroFix plus hose clip. The mask cushion is available in two different sizes. The mask fame integrates the standard mask frame and the forehead frame into one piece with an adjustable hinge design, which forms the central and supporting part of the Papillon nasal mask cushion and forehead pad are fixed to the mask frame prior to use. The mask cushion and forehead pad are both made of a hypoallergenic silicone material. The mask cushion and outer shell are comprised of a single, soft, silicone piece that covers the entire nasal area. The cushion includes an exhalation system consisting of six exhalation vents. The hose connection system allows a standard respiratory hose to be connected to the Papillon nasal mask. The hose connection system includes two connectors for external pressure measurement and for administering O.. The Aerofix headgear and Aerofix plus hose clip are easily connected to the mask frame and the respiratory hose using fasteners. The Aerofix headgear secures the nasal mask to the head of the patient.
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    K Number
    K993094
    Device Name
    AERO-CLICK
    Manufacturer
    MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH
    Date Cleared
    2000-10-23

    (403 days)

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

    MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Exhalation outlet for use between masks without openings and air tube for sleep apnoea therapy including quick connector/disconnector
    Device Description
    The Aero-Click ® is a passive exhalation outlet which is placed in the patient circuit between the mask and the air tube of a sleep apnoea therapy device to provide a continuous leak path for the patients exhaled air. It is placed near the patient's face and allows quick connection/disconnection of the mask from the sleep apnoea therapy device. The device consists of 2 parts which can be easily disconnected. It can be cleaned with dish-washing detergents. Cleaning requires disconnection of the device. The device can be desinfected with Cidex ®.
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