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510(k) Data Aggregation

    K Number
    K991216
    Device Name
    HOFFMAN IVF-1
    Manufacturer
    (ARMS) HOFFMAN SURGICAL EQUIPMENT, IVF DIVISION
    Date Cleared
    1999-08-05

    (118 days)

    Product Code
    MQG
    Regulation Number
    884.6120
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    (ARMS) HOFFMAN SURGICAL EQUIPMENT, IVF DIVISION

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

    To maintain a temperature and pH in an enclosed device for oocyte screening, fertilization identification, cleavage check and embryo transfer.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter for the Hoffman IVF-1 Incubator, a medical device. The document states that the device is substantially equivalent to legally marketed predicate devices. This type of document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications. The letter only confirms FDA clearance based on substantial equivalence.

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