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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 provided text describes the acceptance criteria and the study conducted for the Fetal Doppler, Model FD88 (K182710).

Here's the information broken down as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" for the Fetal Doppler's performance. Instead, it states that the device's "Performance is Same as the predicate device," and then lists the predicate device's performance specifications. Therefore, the predicate device's performance can be inferred as the "acceptance criteria" for substantial equivalence.

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