CORE 500 Digital Stethoscope
K-Number: K230111 · 2023-05-26
ApplicantEko Devices, Inc.
Decision Date2023-05-26
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
CORE 500 Digital Stethoscope is a medical device manufactured by Eko Devices, Inc.. It received FDA 510(k) clearance on 2023-05-26 under approval number K230111. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CORE 500 Digital Stethoscope?
CORE 500 Digital Stethoscope is a medical device that received FDA 510(k) clearance on 2023-05-26. It is manufactured by Eko Devices, Inc.. The 510(k) number is K230111.
When was CORE 500 Digital Stethoscope approved by the FDA?
CORE 500 Digital Stethoscope received FDA 510(k) clearance on 2023-05-26, under approval number K230111.
What company makes CORE 500 Digital Stethoscope?
CORE 500 Digital Stethoscope is manufactured by Eko Devices, Inc..
What is the FDA product code for CORE 500 Digital Stethoscope?
The FDA product code for CORE 500 Digital Stethoscope is DQD.
Related Clinical Trials
Other Devices by Eko Devices, Inc.
Related Devices (Code: DQD)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.