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The Doppler FHR Detector (Model BF-500D+ and BF-560) is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound in patients with singleton pregnancies after 12 weeks of gestation. The device is intended to be used by health care professionals in a hospital, clinic, community, and home setting.

The Fetal Doppler is a hand-held device for non-invasive measurement and display of the fetal heart beat utilizing Doppler ultrasound. The device consists of two main components, the main unit and probe. The main unit consists of the main board, power module, battery, speaker, and liquid crystal display(LCD) screen. The wired probe consists of the transducer and includes two angled semi-circle ultrasonic crystals, one for transmission and one for reception. The ultrasonic signal is continuously transmitted at one frequency. The difference between BF-500D+ and BF-560 are shown as below: - BF-500D+ is powered by a 9V rechargeable Ni-MH battery, and adapter is packaged with the unit; BF-560 is powered by three pieces of 1.5V AA alkaline disposable batteries. - BF-500D+ will display Fetal heart rate, sound volume, and battery indicator; BF-560 will also display the selected working frequency besides in addition to the features of the BF-500D+. - the two models have different probe shapes.

The Ultrasonic Fetal Doppler (Model M520, M521, M523) is intended to detect and display fetal heart rate, and used by health care professionals in a hospital, clinic, community, and home setting for singleton pregnancies after 16 weeks gestation.

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The Pocket Fetal Doppler (Models CONTEC 10D, CONTEC 10E and CONTEC10F) is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in the hospital, clinic, community and home. The device is intended for use at or after 12 weeks gestation.

The Pocket Fetal Doppler is a hand-held fetal Doppler used for non-invasive measurement and numerical display of the fetal heart rate (FHR) utilizing pulsed-wave Doppler ultrasound. The Pocket Fetal Doppler includes three models: CONTEC10E and CONTEC10E and CONTEC10F. All models have four components: upper shell, display and probe. The material for probe cap and shell is ABS. The device contains an ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit. The device is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home. This device can detect a fetal heart rate value at or after twelve weeks gestation. The CONTEC10D is powered by a 3.7V lithium battery, the ultrasonic signal is continuously transmitted at a frequency of 2.5MHz. The CONTEC10E and CONTEC10F is powered by two 1.5V batteries (AA LR6), the ultrasonic signal is continuously transmitted at a frequency of 2.5MHz.

The Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in the hospital, clinic, community and home. The device is intended for use at or after 12 weeks gestation.

The Pocket Fetal Doppler is a hand-held FHR detection device, it is used for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. The Pocket Fetal Doppler consists of two models (CONTEC10C, CONTEC10CL). Both models have two hand-held components, a main unit and a probe. The device contains components of ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit.

The Fetal Doppler is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home. The device is intended for use at or after 16 weeks gestation.

The Fetal Doppler, model TK-T802CR, is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats and sounds. The Fetal Doppler is used for non-invasive detection and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. It has two hand-held components, a main unit and a probe. The main unit consists of the main board, power module, battery, speaker, and LCD screen. The probe consists of the ultrasonic transducers for transmission and for signal reception. The ultrasonic signal is continuously transmitted at a frequency of 2.0, 2.5, or 3.0 MHz, depending on the probe settings selected.

Fetal Doppler is intended to detect fetal heart rate, and play the fetal heart sound. Fetal Doppler is indicated for use by health care professionals in hospital, clinic, community and home for singleton pregnancies after 12 weeks gestation.

Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. Fetal Doppler is indicated for use by used by health care professionals in hospital, clinic, community and home for singleton pregnancies after 12 weeks gestation. It is comprised of an ultrasonic signal transmitter and receiver, analog signal processing unit, FHR calculating unit, and LCD/TFT display control unit. It has audio output and can be connected with headphones or to a recorder with audio input. The Fetal Doppler is powered by a standard 1.5 V DC alkaline battery.

HeraBEAT™ US is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. HeraBEAT™ US is indicated for use by medical professionals in clinical or home care settings for singleton pregnancies from 12 weeks gestation.

HeraBEAT™ US is a hand-held, battery powered audio Doppler device integrated with 2MHz probe, used for detecting and displaying the fetal heart rate (FHR) and FHR sound. The device uses an optical sensor to distinguish between the FHR and the maternal heart rate (MHR) to eliminate "crosstalk" in the FHR display. HeraBEAT™ US includes the following components: - The handheld HeraBEAT™ US device that incorporates an ultrasound transducer, rechargeable battery, and internal microcontroller and Bluetooth Low Energy (BLE) chip for wireless data transfer from the HeraBEAT™ US device to the user's smartphone. - The HeraBEAT™ application, which is downloaded from an app store to the user's smartphone. The HeraBEAT™ application is used to communicate with the HeraBEAT™ US device using wireless BLE. It controls the operation of the device and receives the FHR values for numerical display to the user. It plays the FHR sound and stores the FHR values in a history log. HeraBEAT™US is supplied with a battery charger (power supply), two tubes of commercially available Aquasonic 100 Ultrasound Transmission Gel (cleared under K802146), carry case and User Manual.

The device is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home.

The 510(k) covers four series of Fetal Doppler devices, including FD-200, FD-231, FD-591, and FD-640. Each series contains two models, and four series consists of a total of eight individual models (FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D). The subject devices are used for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. All models have two hand-held components, a main unit and a probe. The main unit consists of the main board, power module, battery, speaker, and LED screen. The probe consists of the ultrasonic transducers for transmission and one for signal reception. The ultrasonic signal is continuously transmitted at a frequency of 2.0. 2.5, or 3.0 MHz, depending on the probe selected. The reflected continuous signal is received, and detected Doppler shift is presented to the user. These devices are intended for use at or after 12 weeks' gestation.

The Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound from early gestation. The device should only be used by a trained medical professional in a clinical setting and is not intended for operated by the patient at home.

The subject device (model FD88) is a hand-held device for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Dopler ultrasound. It includes two major components: main unit and probe. The main unit consists of the main board, power module, battery, speaker, and LCD screen. The main unit is supplied by a rechargeable 3.7V/500mAh Li-ion battery. The wired probe contains two angled semi-circle ultrasonic crystals, one for transmission and the other for reception. The ultrasonic signal is continuously transmitted (at a frequency of 2.5 MHz), received and presented to the user as numerical display. This device is intended to be used after 12 weeks gestation for singleton by a trained health professional in a clinical setting.

The Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate and play the fetal heart sound from early gestation thru delivery for singleton pregnancies. The Fetal Doppler is intended for use by trained healthcare professionals only in a clinical setting.

The Fetal Doppler is a hand-held device for non-invasive measurement and display of the fetal heart beat utilizing the principle of Doppler shift of an ultrasound. The device consists of two main components, the main unit and probe. The main unit consists of the main board, power module, battery, speaker, and organic light-emitting diode screen. The wired probe consists of the transducer and includes two angled semi-circle ultrasonic crystals, one for transmission and one for reception. The ultrasonic signal is continuously transmitted at a frequency of 2 MHz. The reflected continuous wave signal is received by one of the crystals and then any detected Doppler shift is presented to the user.