BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Neteera 130H-Plus Vital Sign Monitoring Sensor

    K Number: K231733 · Decision Feb 9, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    2
    Review Days
    241

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    Basic Information

    Device Name
    Neteera 130H-Plus Vital Sign Monitoring Sensor
    K Number
    K231733
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neteera Technologies , Ltd.
    Date Received
    June 13, 2023
    Decision Date
    February 9, 2024
    Product Code
    DRT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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    Other Clearances by Neteera Technologies , Ltd.

    K Number Device Name
    K212143 Neteera 130H/131H Vital Sign Monitoring Sensor