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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Heartbuds, LLC. It received FDA 510(k) clearance on 2023-03-14 under 510(k) 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. The listed applicant is Heartbuds, LLC. The 510(k) number is K212906.

When did HeartBuds Electronic Stethoscope receive FDA 510(k) clearance?

HeartBuds Electronic Stethoscope received FDA 510(k) clearance on 2023-03-14, under 510(k) number K212906.

Who is the listed applicant for HeartBuds Electronic Stethoscope?

The FDA 510(k) record lists Heartbuds, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HeartBuds Electronic Stethoscope?

The FDA product code for HeartBuds Electronic Stethoscope is DQD.

Related Devices (Code: DQD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261494Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)Shanghai Hulu Devices Co., Ltd.K261694CORE 300 Digital StethoscopeEko Health, Inc.K252915AiSteth®Ai Health Highway India Pvt., Ltd.K252089Tyto Stethoscope (G3)Tyto Care , Ltd.K252076Kneevoice Cartilage Evaluation System (750-3600-001)Kneevoice, Inc.K252284eMurmur Heart AICsd Labs

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.

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