FDA 510(k) Applications for Medical Device Product Code "HEK"
(Monitor, Heart Sound, Fetal, Ultrasonic)

FDA 510(k) Number Applicant Device Name Decision Date
K142769 iCare Newlife Technologies, Inc. Fetal Doppler 03/20/2015
K060410 SUMMIT DOPPLER SYSTEMS, INC. ECHOHEART TRANSVAGINAL DOPPLER PROBE 04/10/2006


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