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510(k) K233609

CORE 500 Digital Stethoscope by Eko Health, Inc. — Product Code DQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2024
Date Received
November 13, 2023
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 by Eko Health, Inc.

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Other clearances for product code DQD

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  • 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)
  • K231551 — Stethophone (October 12, 2023)
  • K230613 — SKEEPER (August 2, 2023)