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510(k) K202062

wheezo WheezeRate Detector by Respiri Limited — Product Code PHZ

K202062 is an FDA 510(k) premarket notification submitted by Respiri Limited for the device "wheezo WheezeRate Detector". The FDA issued a decision of Substantially Equivalent on March 11, 2021. The device falls under product code PHZ (Abnormal Breath Sound Device), a Class II device regulated under 21 CFR 868.1900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2021
Date Received
July 27, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abnormal Breath Sound Device
Device Class
Class II
Regulation Number
868.1900
Review Panel
AN
Submission Type

The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.

Other clearances for product code PHZ

  • K252844 — Tyto Insights for Wheeze Detection (with PCCP) (June 2, 2026)
  • K243567 — Tyto Insights for Rhonchi Detection (April 7, 2025)
  • K240555 — Tyto Insights for Crackles Detection (July 2, 2024)
  • K232237 — Tyto Insights for Wheeze Detection (December 13, 2023)
  • K221614 — TytoCare Lung Sounds Analyzer (February 24, 2023)
  • K131285 — SONOSENTRY (August 19, 2014)

FDA data resources