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510(k) Data Aggregation

    K Number
    K241799
    Device Name
    ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C
    Manufacturer
    ATMOS MedizinTechnik GmbH & Co. KG
    Date Cleared
    2025-03-07

    (259 days)

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

    **ATMOS MedizinTechnik GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATMOS C 051 Thorax is indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids, or infectious material from a patient's respiratory system after surgery. The general indication of the ATMOS C 051 Thorax is thoracic drainage.
    Device Description
    The ATMOS C 051 Thorax (317.0200.0) drainage system is a device for mobile, digital thoracic drainage. It is portable, mains-independent and has an electronic monitoring system with optical and acoustic display. The device takes medical effect as a system in combination with a secretion canister and a hose system. The system creates the (natural) vacuum in the pleural cavity by draining off air and secretion. The ATMOS C 051 Thorax is equipped with a rechargeable battery. A charging unit which is located within the suction device guarantees the secure charging of the battery. The hose system is rinsed with air at regular intervals to prevent the collection of debris in the hose. Bacterial and viral filters in the secretion canister and measuring hose prevent contaminated secretions from entering the device. The device is equipped with a disposable strap and a carrying handle. These enable mobility. A universal bracket or the standard rail bracket can be ordered separately as accessories. The ATMOS C 051 Thorax is a reusable device delivered in non-sterile state. The secretion canister and hose systems are single-use devices and delivered sterile. All other accessories subject to this submission are reusable and delivered non-sterile.
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    K Number
    K232015
    Device Name
    ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)
    Manufacturer
    ATMOS MedizinTechnik GmbH & Co. KG
    Date Cleared
    2023-08-03

    (28 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    **ATMOS MedizinTechnik GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ATMOS Scope is used for endoscopic diagnosis within the nasal lumens and airway anatomy and is intended to provide visualization via a monitor. The ATMOS Scope may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique.
    Device Description
    The ATMOS Scope is a flexible nasopharyngo laryngoscope for endoscopic diagnosis within the nasal lumens and airway anatomy. The device is an electrical device and consists of a handle for the user and a flexible, steerable part that is inserted into the patient. The deflection lever can be easily operated with the thumb and enables precise control of the endoscope tip at an angle of 2 x 135°. This makes it easy to examine even hard-to-reach regions in the nose, or throat. The device contains two integrated LED light sources that provide bright and homogeneous illumination in the complete field of view. With the help of a 1280 x 800-pixel image sensor at the flexible part and the electronics built into the handle, a digital image is generated. For taking and saving photos and videos, the ATMOS Scope has two separate function keys located directly on the handle. This can be displayed as the endoscopic image on a connected PC with video software. The endoscopic image is used for visual diagnostics by the user. The ATMOS Scope is delivered in a non-sterile condition.
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