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510(k) K160401

Tyto Stethoscope by Tyto Care , Ltd. — Product Code DQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2016
Date Received
February 12, 2016
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

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  • K232237 — Tyto Insights for Wheeze Detection (December 13, 2023)
  • K221614 — TytoCare Lung Sounds Analyzer (February 24, 2023)
  • K190242 — Tyto Thermometer (March 27, 2019)
  • K181612 — Tyto Stethoscope (OTC) (December 17, 2018)

Other clearances for product code DQD

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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)
  • 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)