B-K Medical Aps

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Contact: Lars Hansen
Web: http://www.bkmed.com
E-Mail:
Address: Mileparken 34, Herlev DK-2730, Denmark
Phone: +45-(0)-44528100 | Fax: +45-(0)-44528199 | Map/Directions >>

Profile: B-K Medical Aps specializes in the development and production of diagnostic ultrasound systems. Our Flex Focus is a fully featured, mobile ultrasound solution. it is a small, lightweight system that goes easily to point-of-care. It is small enough in size to physically fit into any clinical setting, even smaller, private practice offices. We offer office solutions for urologists to perform all procedures in their own office and avoid sending patients to hospital examinations.

FDA Registration Number: 9680269
US Agent: Albert C. Cefalo / Analogic Corporation
Phone: +1-(978)-326-4485 Fax: +1-(978)-977-6809 E-Mail:

5 Products/Services (Click for related suppliers)

• Biopsy Needle Kit (FDA Code: FCG / 876.1075)

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Brace Setting Twister (FDA Code: ITO / 890.3410)

An external limb orthotic component is a device intended for medical purposes for use in conjunction with an orthosis (brace) to increase the function of the orthosis for a patient's particular needs. Examples of external limb orthotic components include the following: A brace-setting twister and an external brace stirrup.

• Diagnostic Ultrasonic Transducer (FDA Code: ITX / 892.1570)

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

• Ultrasonic Puls-Echo Scanner (FDA Code: IYO / 892.1560)

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Ultrasonic Pulsed Doppler Imaging System (FDA Code: IYN / 892.1550)

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.