LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K952172
    Device Name
    HOTMAN
    Manufacturer
    HEMO SAPIENS, INC.
    Date Cleared
    1997-06-10

    (764 days)

    Product Code
    DSB
    Regulation Number
    870.2770
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found.

    Device Description

    HOTMAN (Hemodynamic and Oxygen Transport Monitoring and Manaqing System)

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a device called "HOTMAN (Hemodynamic and Oxygen Transport Monitoring and Managing System)". This document does not contain any information about the acceptance criteria or a study proving the device meets those criteria. It is purely a regulatory approval letter.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on the input provided.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1