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510(k) K170874

Eko Model E5 System (EME5), Eko DUO by Eko Devices, Inc. — Product Code DQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2017
Date Received
March 24, 2017
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 Devices, Inc.

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  • K213794 — Eko Murmur Analysis Software (EMAS) (June 29, 2022)
  • K200776 — Eko CORE (April 6, 2020)
  • K192004 — Eko Analysis Software (January 15, 2020)
  • K151319 — Eko Electronic Stethoscope System (August 28, 2015)

Other clearances for product code DQD

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  • 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)