FDA 510(k) Applications Submitted by Sam Huang, Ph.D.

FDA 510(k) Number Submission Date Device Name Applicant
K233409 10/06/2023 Eko Low Ejection Fraction Tool (ELEFT) Eko Health, Inc.
K233609 11/13/2023 CORE 500 Digital Stethoscope Eko Health, Inc.
K213794 12/06/2021 Eko Murmur Analysis Software (EMAS) Eko Devices, Inc.
K230111 01/17/2023 CORE 500 Digital Stethoscope Eko Devices, Inc.


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