CORE 500 Digital Stethoscope— 510(k) K230111

Substantially Equivalent

Eko Devices, Inc.

FDA 510(k) clearance K230111 for CORE 500 Digital Stethoscope, Substantially Equivalent on 2023-05-26. Applicant: Eko Devices, Inc..

Clearance details

Applicant: Eko Devices, Inc.
Product code: Code DQD
Advisory panel: Cardiovascular
Date received: 2023-01-17
Decision date: 2023-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.