Home / 510(k) Clearances / K212906

510(k) K212906

HeartBuds Electronic Stethoscope by Heartbuds, LLC — Product Code DQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2023
Date Received
September 13, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stethoscope, Electronic
Device Class
Class II
Regulation Number
870.1875
Review Panel
CV
Submission Type

Other clearances for product code DQD

  • K252089 — Tyto Stethoscope (G3) (March 12, 2026)
  • K252076 — Kneevoice Cartilage Evaluation System (750-3600-001) (February 6, 2026)
  • K252284 — eMurmur Heart AI (December 19, 2025)
  • K252595 — Stethophone Pro (September 12, 2025)
  • K251494 — Eko Foundation Analysis Software with Transformers (EFAST) (August 12, 2025)
  • K242971 — AccurSound Electronic Stethoscope (AS101) (November 25, 2024)
  • K240901 — Stethophone (September 19, 2024)
  • K233313 — Keikku Electronic stethoscope (April 10, 2024)
  • K233609 — CORE 500 Digital Stethoscope (March 28, 2024)
  • K231551 — Stethophone (October 12, 2023)