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Is the Sonolife Baby Doppler a medical device?

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Is the Sonolife Baby Doppler a medical device?

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THE SONOLIFE BABY DOPPLER IS NOT A MEDICAL DEVICE AND SHOULD NOT BE USED OR RELIED UPON IN ANY WAY FOR DIAGNOSTIC OR OTHER MEDICAL PURPOSES. ANY CONCERNS ABOUT YOUR PREGNANCY SHOULD BE ADDRESSED TO A MEDICAL PRACTITIONER. THIS IS NOT INTENDED TO REPLACE REGULAR PHYSCIANS VISITS.

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