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510(k) Data Aggregation

    K Number
    K955890
    Device Name
    FIRST MEDIC PULSE OXIMETRY MODULE
    Manufacturer
    COLORADO MEDTECH, INC.
    Date Cleared
    1997-07-28

    (577 days)

    Product Code
    MKJ
    Regulation Number
    870.5310
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FIRST MEDIC PULSE OXIMETRY MODULE

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA letter granting 510(k) clearance for the First Medic 710 Oximetry Module. It confirms substantial equivalence but does not contain information about acceptance criteria or specific study details often found in scientific publications or the 510(k) submission itself.

    Therefore, I cannot provide the requested information based solely on the provided text. The document is a regulatory approval letter, not a scientific study report.

    To answer your questions, I would need access to the actual 510(k) submission (K955890) from Physio-Control Corporation, which would contain the clinical data, acceptance criteria, and study details.

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