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510(k) Data Aggregation

    K Number
    K102718
    Device Name
    DIGITAL THERMOMETER; DIGITAL THERMOMETER
    Manufacturer
    INTERNATIONAL REGULATORY CONSULTANTS, LLC (IRC)
    Date Cleared
    2010-12-13

    (83 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL REGULATORY CONSULTANTS, LLC (IRC)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To measure the human body temperature in regular mode orally, rectally or underarm. The devices are reusable for clinical or home use on people of all ages.
    Device Description
    The GF-MT501 and GF-MT502 digital thermometer comprise of a thermistor for measuring sensor, a reference resistor for comparison of the temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts. The thermometers use a DC 1.5V battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays ' in LCD display.
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    K Number
    K981591
    Device Name
    VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT
    Manufacturer
    INTERNATIONAL REGULATORY CONSULTANTS
    Date Cleared
    1998-10-09

    (158 days)

    Product Code
    FAD
    Regulation Number
    876.4620
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL REGULATORY CONSULTANTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Both the VORTEK and BIOSOFT versions of the ureteral double loop stent are intended for the exact same use as the current silicone ureteral double loop stent. The ureteral double loop stent are intended for drainage of the upper urinary tract where indicated such as in the case of ureteral obstruction, fistula, calculus debris/fragmentation, tumor, etc. The "flush" ureteric configuration with certain models (reference numbers) is intended to flush the lithiasis to the kidney before ESWL.
    Device Description
    VORTEK® and BIOSOFT® Ureteral Double Loop Stents
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    K Number
    K971347
    Device Name
    MEDISURF
    Manufacturer
    INTERNATIONAL REGULATORY CONSULTANTS
    Date Cleared
    1997-07-03

    (84 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL REGULATORY CONSULTANTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MediSurf is intended to facilitate access to clinical images and information in distributed locations. Along with image processing capabilities, MediSurf can be used by radiologists for on-call teleradiology over "intranets", Internet, direct or dial-up lines, and for providing second opinion services. It can also be used by physicians for enhanced interpretation of cases through the inclusion of images in imaging related reports and in patient records in general. Similarly it can be used by healthcare organization staff for facilitated access to clinical images throughout the healthcare organization.
    Device Description
    The MediSurf server is an access engine to healthcare information. MediSurf provides its end-users with easy access to DICOM devices and networks for the retrieval of images in full diagnostic quality using adaptive progressive compression for efficient transfer over different communication links. The server also provides the user with the software applets needed to display, process, store, and send the retrieved clinical data. The MediSurf server is based on off-the-shelf UNIX based computer that complies with the accepted international standards for computer systems. The system also comprises software developed and validated by Algotec Systems Ltd..
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    K Number
    K962614
    Device Name
    SHIFA STERILE DISPOSABLE SYRINGES
    Manufacturer
    INTERNATIONAL REGULATORY CONSULTANTS
    Date Cleared
    1996-09-06

    (65 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL REGULATORY CONSULTANTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Shifa Syringes are intended for injection of
    Device Description
    Shifa Syringes are sterile disposable medical piston syringes consisting of barrel with luer-lock or slip-lock nozzle, gasket, and a needle. They are sold with or without needles. The barrel, and plunger are polypropylene, the gasket is natural rubber, and the needle is stainless steel.
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