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510(k) Data Aggregation

    K Number
    K101960
    Device Name
    SONOTRAX SERIES ULTRASONIC POCKET DOPPLER
    Manufacturer
    EDAN INSTRUMENTS, INC.
    Date Cleared
    2010-08-10

    (29 days)

    Product Code
    HEP, KNG
    Regulation Number
    884.2660
    Why did this record match?
    Product Code :

    HEP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sonotrax series of Ultrasonic Pocket Doppler are intended for use by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physicians assistants, by nurses, midwives, ultrasound volumes. In hospitals, clinics and private offices. The 2 MHz and/ or 3 MHz obstetrical probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma. The 4 MHz, 5 MHz and/or 8 MHz vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.
    Device Description
    The Sonotrax series Ultrasonic Pocket Doppler is a hand-held device The Sonotrax Schoolino and display of fetal heart rate and for non-invasive incasurement and inciple of Doppler shift of an ultrasound. The ultrasound is transmitted from the probe to patient Dody (maternal abdominal wall), and moves through biophysical objects. The acoustic ultrasound is reflected by blood and moving objects. The acoustic articles The reflected ultrasound is received by the probe and is converted into electric signals. The waveform data are applied to the CPU for all the digital The waveronm 'data- are 'upperation keys. The audio signal is taken processing on LCD Diopia), episer to generate the analogue signals before digital processing. The following probes are supplied with the Ultrasonic Pocket Doppler: 1. 2MHz for fetal heart rate. 2. 3MHz for fetal heart rate 2. SIMIZ for fetal neart face taxe 3. 4MHz for detections of arterial and venous blood flow velocity. 5. 4MHz for detections of arterial and venous blood flow velocity. 4. 3MHz for detections of arterial and venous blood flow velocity.
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    K Number
    K023082
    Device Name
    BABYCARE
    Manufacturer
    BIONET COMPANY LTD
    Date Cleared
    2003-03-03

    (167 days)

    Product Code
    HEP
    Regulation Number
    884.2660
    Why did this record match?
    Product Code :

    HEP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BABYCARE is a fetal ultrasonic monitor designed to transmit and receive ultrasonic energy into and from the pregnant woman by means of continuous wave (doppler) echoscopy. BABYCARE is a compact pocket Doppler, and it is intended for use to display the measured Fetal Heart Rate on LCD and to allow the user to hear a crystal clear Fetal Heart Beat Sound.
    Device Description
    BABYCARE is a fetal ultrasonic monitor designed to transmit and receive ultrasonic energy into and from the pregnant woman by means of continuous wave (doppler) echoscopy. BABYCARE is a compact pocket Doppler, and it is intended for use to display the measured Fetal Heart Rate on LCD and to allow the user to hear a crystal clear Fetal Heart Beat Sound. Being operated with battery, it allows babies to be checked anywhere, at any time. Using high sensitive and harmless ultrasound sensor, it detects and displays the accurate FHR on the LCD. BABYCARE is especially suitable for routine use in OB/GYN. Features: - Accurate FHR detection & display - - Clear sound offered from separate speaker - - Cap-shaped speaker for probe protection - - -Compact size and battery operated - Harmless ultrasound sensor " - Easy to use - Technical Specifications: - Display: 3-digit segment ー - FHR Measuring Range: 50-240 bpm - - Measurement Resolution: ± 3bpm - - Speaker output power: 1 W - - Ultrasound frequency: 2.0 Mhz - - Power: 9V batterv - - Sensitivity: 12 Weeks Fetus - - Weight: 290g (without battery) ~ - Standard Accessory: Gel, 9V battery --
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