Search Filters

Search Results

Found 8 results

510(k) Data Aggregation

    K Number
    K070511
    Device Name
    RICHTER MALE LATEX CONDOM
    Date Cleared
    2008-01-14

    (326 days)

    Product Code
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    **RICHTER **RUBBER TECHNOLOGY SBN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Richter Male Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
    Device Description
    This condom is made of a natural rubber latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is colorless, non flavored, non scented; straight walled with a reservoir tip. The nominal length is 185 mm, nominal width, 54 mm and nominal thickness 0.07mm. It is lubricated with silicone (viscosity 250 cps), and cornstarch is used as a dressing material. This condom conforms to current established national and international voluntary standards including ASTM D3492 and ISO 4074.
    Ask a Question

    Ask a specific question about this device

    K Number
    K052844
    Device Name
    KAVS - CATHETER, MODELS 1107100 & 1107060
    Manufacturer
    Date Cleared
    2006-03-20

    (164 days)

    Product Code
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    **RICHTER **& ROTHE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The KAVS Catheter is intended to temporarily inhibit blood flow in isolated sections of peripheral veins in order to inject physician prescribed medications.
    Device Description
    The KAVS catheter is an intravascular catheter that is introduced into the patient's vein for short-term therapeutic use. The catheter has a balloon at the distal end, that when expanded, will temporarily block the blood flow in that segment of the vein. This allows the physician to inject medication through the central lumen of the catheter for patient treatment. Once the treatment is complete the physician can then remove the medication, prior to removing the catheter. The KAVS catheter is a double-lumen catheter made of radio-opaque polyurethane, which is equipped with a latex balloon at the distal end. At the proximal end of the coaxial catheter there is a double attachment, consisting of a Luer-lock adapter for access to the main catheter lumen, for injection of prescribed medication, and a laterally mounted Luer-lock adapter with a stopcock for filling the balloon. The rounded catheter tip is closed, underneath the balloon there are three openings, which serve as outlet openings for the main catheter lumen.
    Ask a Question

    Ask a specific question about this device

    K Number
    K053486
    Device Name
    TREND 200 CPAP DEVICE, MODEL 5CP201; TRENDSET PC SOFTWARE, MODEL TRENDSET
    Manufacturer
    Date Cleared
    2006-01-04

    (20 days)

    Product Code
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOFF**RICHTER **GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TREND 200 device is for treatment of obstructive sleep apnea (OSA) in adult patients weighing at least 30 kg. These devices are not intended for use with ventilator-dependent patients. The TREND 200 device provides continuous positive airway pressure. The TRENDset PC Software is a program for reading the TREND CPAP device patient compliance data.
    Device Description
    The Hoffrichter TREND 200 device provides mono-level CPAP treatment levels over the clinician settable range of 4 to 18 cmH2O. The TREND 200 CPAP device is modification of the TREND 110 CPAP device which adds the following features: - Real time clock with wake-alarm support. . - Audible tone generator with audible alert functions. . - EEPROM capacity increased to store times of device use (patient compliance . data). - Serial port which can transmit the stored times of device use. . - TRENDset PC software which may be used by the clinician to communicate . TRENDSETT O sollware which may be and print the patient compliance data (times of use). - DC power inlet for alternate power source option. . The TREND 200 CPAP device is provided in a compact lightweight THE TREND 200 OF .. See and utilizes the same form factor and enclosure for Casy bodolae acce, and 16 character LCD display with keys accessones as the 7 (END 170 the user with displayed information about on the operator panel provides the access to menus for soft-start ramp, clinical the treathern (set by doctor, PIN code protected), day/date/wake-alarm, prescription (SCL by doctor) nower supply automatically supply adapts to regional mains voltage (115 to 230 VAC). Standard accessories include treatment tubing with integrated Standard - aoceoonoo - including - including available masks and swivels are specified. As in the TREND 110, TREND 200 treatment pressure is measured as As in the 7AEND 110, 178, 1782AB by means of a measuring tube integrated into the therapy tubing. This maximizes accuracy and control of megrated into the therapy tabing. pressure and accounts for losses due to the therapy delivery circuit. Hoffrichter CPAP devices are prescription use devices, and are not intended for life supporting or life sustaining applications.
    Ask a Question

    Ask a specific question about this device

    K Number
    K041035
    Device Name
    HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDIFIER ACCESSORY FOR TREND
    Manufacturer
    Date Cleared
    2004-06-09

    (49 days)

    Product Code
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOFF**RICHTER **GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TREND 110 device is for treatment of obstructive sleep apnea (OSA) in adult patients weighing at least 30 kg. These devices are not intended for use with ventilator-dependent patients. The TREND 110 device provides continuous positive airway pressure. The AquaTREND Humidifier accessory provides humidification of the air delivered to the patient.
    Device Description
    Hoffrichter TREND 110 devices provide mono-level CPAP treatment levels over the clinician settable range of 4 to 18 cmH₂O. The TREND 110 CPAP device is provided in a compact lightweight enclosure for easy bedside use. A 2 x 16 character LCD display with keys on the operator panel provides the user with displayed information about the treatment level as well as access to menus for soft-start ramp, clinical prescription (set by doctor, PIN code protected) and hours of operation. TREND 110's power supply automatically supply adapts to regional mains voltage (115 to 230 VAC). Heated humidification is available by installing the AquaTREND /// heated humidifier accessory. A key with LED indicator permits the user to select the humidification level. Moisture contacting materials in the humidifier and therapy tube meet biocompatibility requirements. Treatment pressure is measured as close as possible to the patient mask Freathern of a measuring tube integrated into the therapy tubing. This maximizes accuracy and control of pressure and minimizes losses due to the therapy delivery circuit. TREND 110 has a user selectable ramp function, which starts with a reduced pressure and gradually increases to the treatment pressure to make it more comfortable to fall asleep. The user can adjust the ramp time in 10 minute increments to 0 (no ramp), 10, 20, or 30 minutes. Standard accessories include treatment tubing with integrated measurement tube and headgear. Commercially available masks and swivels are specified. Hoffrichter CPAP devices are prescription use devices, and are not intended for life supporting or life sustaining applications.
    Ask a Question

    Ask a specific question about this device

    K Number
    K014074
    Device Name
    HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION
    Manufacturer
    Date Cleared
    2003-07-23

    (590 days)

    Product Code
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOFF**RICHTER **GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Scalar, Scalar Plus, Vector, and Vector Plus devices are for treatment of obstructive sleep apnea (OSA) in adult patients weighing at least 30 kg. These devices are not intended for use with ventilator-dependent patients. The Scalar, Scalar Plus, Vector Plus devices provide continuous positive airway pressure. The Scalar Plus and Vector Plus devices provide humidification of the air delivered to the patient.
    Device Description
    Hoffrichter SCALAR and VECTOR CPAP devices provide mono-level CPAP treatment levels over the clinician settable range of 3 to 18 cmH2O. All devices are constructed on a common platform, including case, mechanical and pneumatic components, operator panel, and electronic control system. A 2 x 16 character display with keys on the operator panel provides the user with displayed information about the treatment level as well as access to menus for time/date, ramp and other functions. VECTOR's power supply automatically supply adapts to regional mains voltage (115 to 230 VAC), whereas SCALAR is set to the region (115 or 230 VAC) by rear panel switch. Models with a Plus designation include integrated heated humidification. An adjustment dial permits the user to select the humidification level. Moisture contacting materials in the breathing circuit meet biocompatibility requirements. Treatment pressure is measured as close as possible to the patient mask by means of a measuring tube integrated into the therapy tubing. This maximizes accuracy and control of pressure and minimizes losses due to the therapy delivery circuit. Hoffrichter CPAP devices have a user selectable ramp function, which starts with a reduced pressure and slowly increases to the treatment pressure to make it more comfortable to fall asleep. The user can adjust the ramp time from 0 to 60 minutes. A mask test may be initiated at the full treatment pressure before the ramp begins to check for mask leaks. Accessories include treatment tubing with integrated measurement tube and headgear. Commercially available masks and swivels are specified. A serially connected remote control device, the MULTI 20, supplied for clinician use during patient tests, emulates operator panel functions. Hoffrichter CPAP devices are prescription use devices, and are not intended for life supporting or life sustaining applications.
    Ask a Question

    Ask a specific question about this device

    K Number
    K011480
    Device Name
    VIVA
    Date Cleared
    2001-05-24

    (10 days)

    Product Code
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    **RICHTER **RUBBER TECHNOLOGY SDN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

    K Number
    K993283
    Device Name
    OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C
    Date Cleared
    1999-12-29

    (90 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARNOLD & **RICHTER **CINE TECHNIK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pacs Unit ARRI OSCAR NET/CD will be used to acquire, display, process, archive, retricve, and transmit diagnostic medical images and information about these images in a single user or network enviroment. The typical users are trained medical professionals.
    Device Description
    The device is intendet to be used to convert an medical film/S-VHS Tape -Image into a digital format(DICOM), electronic storage for an medical image and electronic tranfer of medical image data.
    Ask a Question

    Ask a specific question about this device

    K Number
    K973115
    Device Name
    ARRIPRO 35 ST/TV
    Date Cleared
    1997-09-02

    (13 days)

    Product Code
    Regulation Number
    892.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARNOLD & **RICHTER **CINE TECHNIK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is used for the diagnosis and quantitative. evaluation of 35 mm cine radiographic images, which i originating from radiographic imaging like Angiography. The device contains a visible light source covered with a translucent front that is intended to be used to view medical cine radiographic images (CFR 21 part 892.1890). It also allows to be used for wall projection. The medical device is not part of a diagnostic x-ray system. The device may only be operated in cathlabs, lecture halls and doctors' consulting rooms. The device is only for use by medical professionals.
    Device Description
    The ARRIPRO 35 was designed to fulfil the special requirements in view of an increasing demand for image quality and evaluation precision of 35 mm cardangiofflm material which could only be met with the innovative development of a practice-oriented projector. This projector which was developed using state-of-the-art technology for ease of operation, has an outstanding image quality for the projection, diagnosis and quantitative evaluation of 35 mm cine radiographic images. The ARRIPRO 35 St / TV has the following functions: Rapid Film Transport and Simple Operation, Optimized Image Quality with Flicker Free Projection, High Speed Shuttle, Revolving Lamp Holder, Optimum Wall Projection, Computer and Video Connections, B&W-CCD-TV Camera.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1