Eko Murmur Analysis Software (EMAS)— 510(k) K213794

Substantially Equivalent

Eko Devices, Inc.

FDA 510(k) clearance K213794 for Eko Murmur Analysis Software (EMAS), Substantially Equivalent on 2022-06-29. Applicant: Eko Devices, Inc..

Clearance details

Applicant: Eko Devices, Inc.
Product code: Code DQD
Advisory panel: Cardiovascular
Date received: 2021-12-06
Decision date: 2022-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, CA, US

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