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510(k) Data Aggregation

    K Number
    K171235
    Device Name
    OmniCap
    Manufacturer
    Date Cleared
    2018-01-04

    (252 days)

    Product Code
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Respirion, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The use of the OmniCap™ capnometer is indicated to provide measurement and monitoring of carbon dioxide concentration of the expired breath and respiration rate of adult patients. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a qualified healthcare provider. Environment of Use: Hospitals, Sub-acute care facilities and intra-hospital transport.
    Device Description
    The OmniCap system incorporates three parts: - . OmniCap monitor - . Sensor cartridge with a colorimetric litmus media - AC power adapter . The OmniCap monitor houses the electronics including the color sensor, a LED light source, a miniature vacuum pump, internal sample gas tubing, a rechargeable nickel metal hydride battery pack, and the user interface. The OmniCap Sensor cartridge is a colorimetric litmus media sealed in a plastic cartridge with clear windows on each side. The AC power adapter is IEC 60601-1 compliant. The AC power adapter converts supplied AC power to DC power to facilitate charging the battery. The OmniCap unit can operate with or without the AC adapter connected and powered.
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