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510(k) K220766

eMurmur Heart AI by Csd Labs GmbH — Product Code DQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2022
Date Received
March 16, 2022
Clearance Type
Special
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 Csd Labs GmbH

  • K252284 — eMurmur Heart AI (December 19, 2025)
  • K181988 — eMurmur ID (April 17, 2019)

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  • K242971 — AccurSound Electronic Stethoscope (AS101) (November 25, 2024)
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  • K233313 — Keikku Electronic stethoscope (April 10, 2024)
  • K233609 — CORE 500 Digital Stethoscope (March 28, 2024)
  • K231551 — Stethophone (October 12, 2023)