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510(k) K131285

SONOSENTRY by Isonea, Ltd. — Product Code PHZ

K131285 is an FDA 510(k) premarket notification submitted by Isonea, Ltd. for the device "SONOSENTRY". The FDA issued a decision of Substantially Equivalent on August 19, 2014. 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
August 19, 2014
Date Received
May 6, 2013
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)
  • K202062 — wheezo WheezeRate Detector (March 11, 2021)

FDA data resources