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510(k) K252284

eMurmur Heart AI by Csd Labs — Product Code DQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2025
Date Received
July 22, 2025
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 Csd Labs

  • K220766 — eMurmur Heart AI (May 31, 2022)
  • K181988 — eMurmur ID (April 17, 2019)

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