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510(k) K240901

Stethophone by Sparrow Acoustics, Inc. — Product Code DQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2024
Date Received
April 2, 2024
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 Sparrow Acoustics, Inc.

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  • 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)
  • K233313 — Keikku Electronic stethoscope (April 10, 2024)
  • K233609 — CORE 500 Digital Stethoscope (March 28, 2024)
  • K231551 — Stethophone (October 12, 2023)
  • K230613 — SKEEPER (August 2, 2023)