Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K113007
    Device Name
    BIONIME DIABETES MANAGEMENT SYSTEM VI.0
    Manufacturer
    BIONIME CORPORATION
    Date Cleared
    2012-02-27

    (143 days)

    Product Code
    JQP, NBW
    Regulation Number
    862.2100
    Why did this record match?
    Product Code :

    JQP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bionime Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from Rightest® Glucose meter(s) to a personal computer for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users' profile and data. Bionime Rightest™ GM550 and GM250 meters are compatible with Bionime Diabetes Management System. The Bionime Diabetes Management System is not intended to provide treatment decisions, nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed healthcare professional.
    Device Description
    The Bionime Diabetes Management System allows the transfer of blood glucose readings from a compatible Bionime Rightest™ Glucose Meter to a PC via USB cable. The Data analysis features enable the user(s) to view and analyze blood glucose readings from different meal times or time periods up to 90 days. Other features including data tables, trend charts, pie charts, and printed reports are available for viewing and analyzing these readings within the different time slots. The system includes: 1) Installation CD with setup files for Bionime GP200 Diabetes Assistant Software and Rightest™ PC Link Adapter Driver, 2) GP550 PC Link Adapter.
    Ask a Question
    K Number
    K983468
    Device Name
    FASTTAKE ADAPTER, MODEL # P/N 020-072-01
    Manufacturer
    SELFCARE, INC.
    Date Cleared
    1998-12-17

    (77 days)

    Product Code
    JQP
    Regulation Number
    862.2100
    Why did this record match?
    Product Code :

    JQP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lifescan FastTake® Adapter is an accessory to the Lifescan FastTake® Blood Glucose Meter. It provides a communication link between the FastTake® Meter and the Lifescan ONE TOUCH® Interface cable, neither of which is included. The FastTake Adapter is intended to be used for data transfer between a FastTake® Meter and a personal computer.
    Device Description
    The FastTake" Adapter is an accessory to the FastTake Blood Glucose Meter. lt provides a communication link between the FastTake Meter and the ONE TOUCH® cable, neither of which is included with the Adapter. The FastTake Adapter is intended to be used for data transfer between a FastTake Meter and a personal computer.
    Ask a Question
    K Number
    K964460
    Device Name
    THE ROBOLITE
    Manufacturer
    SHAI SYG MOTION AND INNOVATIONS, LTD.
    Date Cleared
    1997-01-24

    (78 days)

    Product Code
    JQP
    Regulation Number
    862.2100
    Why did this record match?
    Product Code :

    JQP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ROBOLITE is an automatic needle guidance system that provides means for accurate positioning of a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions.
    Device Description
    The ROBOLITE is an automatic needle guidance system that provides means for accurate positioning of a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions. The ROBOLITE I S an attachment to and is mounted on a parent mammography system. It comprises a robotic biopsy unit and a film read out and motor control evaluation unit. After creating a stereotactic exposure of a previously detected breast lesion, the Robolite drives a needle holder along three orthogonal axes so that the needle penetrates the precise location of the lesion. The ROBOLITE can be used for fine for core biopsy by using the reqular needle aspiration (FNA) or carrier with a biopsy gun. needle with either plain film with a The ROBOLITE can be used X-ray or digital camera.
    Ask a Question

    Page 1 of 1