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    K Number
    K971444
    Device Name
    3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES
    Manufacturer
    3M MEDICAL PRODUCTS GROUP
    Date Cleared
    1997-06-11

    (51 days)

    Product Code
    DRX
    Regulation Number
    870.2360
    Why did this record match?
    Applicant Name (Manufacturer) :

    3M MEDICAL PRODUCTS GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3M™ Red Dot™ 2234 & 2266 Radiolucent Monitoring Electrodes are intended for use in ECG Monitoring Procedures. The 2234 & 2266 Radiolucent Monitoring Electrodes can be used in all ECG applications where standard ECG monitoring electrodes are used. These electrodes can be used for short term and long term (up to 3 days) monitoring.
    Device Description
    The 3MTM Red Dot™ 2234 & 2266 Radiolucent Monitoring Electrodes are a selfadhesive, non-sterile, single use, disposable electrode which includes a silver/silver chloride sensing element and conductive gel. These electrodes include a self-adhesive tape backing which holds the conductive elements of the electrode in place on the patient's skin for short or long term (up to 3 days) for ECG monitoring. The 3MTM Red Dot™ 2234 & Radiolucent Monitoring Electrode with Clear Tape is composed of the same materials as the predicate device 3MTM Red Dot™ 2234 Radiolucent Monitoring Electrode (K939312) with the exception of the snap which has been modified to include a higher percentage of carbon. The 3M™ Red Dot™ 2266 Radiolucent Monitoring Electrode with Breathable Comfort Backing is composed of the same materials as the predicate device 3M™ Red Dot™ 2234 Radiolucent Monitoring Electrode (K939312) with the exception of the sensing snap which has been modified to include a higher percentage of carbon and the tape backing and adhesive.
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    K Number
    K955103
    Device Name
    3M NO STING BARRIER FILM
    Manufacturer
    3M MEDICAL PRODUCTS GROUP
    Date Cleared
    1996-02-05

    (89 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    3M MEDICAL PRODUCTS GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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