HeartBuds Electronic Stethoscope
K-Number: K212906 · 2023-03-14
ApplicantHeartbuds, LLC
Decision Date2023-03-14
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
HeartBuds Electronic Stethoscope is a medical device manufactured by Heartbuds, LLC. It received FDA 510(k) clearance on 2023-03-14 under approval number K212906. 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 HeartBuds Electronic Stethoscope?
HeartBuds Electronic Stethoscope is a medical device that received FDA 510(k) clearance on 2023-03-14. It is manufactured by Heartbuds, LLC. The 510(k) number is K212906.
When was HeartBuds Electronic Stethoscope approved by the FDA?
HeartBuds Electronic Stethoscope received FDA 510(k) clearance on 2023-03-14, under approval number K212906.
What company makes HeartBuds Electronic Stethoscope?
HeartBuds Electronic Stethoscope is manufactured by Heartbuds, LLC.
What is the FDA product code for HeartBuds Electronic Stethoscope?
The FDA product code for HeartBuds Electronic Stethoscope is DQD.
Related Clinical Trials
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.