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510(k) Data Aggregation

    K Number
    K023618
    Device Name
    SONICAID ONE
    Manufacturer
    OXFORD INSTRUMENTS MEDICAL LTD.
    Date Cleared
    2003-01-22

    (85 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Type
    Special
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    OXFORD INSTRUMENTS MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sonicaid®One Fetal Heart Detector intended use is designed for early detection of fetal life and confirmation of continued life during pregnancy and labour.

    Device Description

    Sonicaid® One Fetal Heart Detector

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Sonicaid® One Fetal Heart Detector. It primarily addresses the substantial equivalence of the device to a predicate device and regulatory compliance. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval rather than a detailed performance study.

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