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510(k) Data Aggregation

    K Number
    K052619
    Device Name
    THE FINGER GUARD
    Manufacturer
    T F & G PRODUCTS
    Date Cleared
    2006-01-06

    (105 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    **T F **& G PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Finger Guard® is intended for use as an accessory to a pulse oximeter reusable finger sensor / probe. When the clear Guard is placed on a digit and the sensor / probe placed over the Guard, it may provide a minimum barrier protection between the digit upon which it is placed and the probe. It can be used anywhere a pulse oximeter is needed.
    Device Description
    The device is a tubular clear sheath/sleeve. It has an opening for insertion of a digit. The sleeve is placed on the digit, and the pulse oximeter sensor/probe is placed over the sleeve/sheath.
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