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510(k) K131285

SONOSENTRY by Isonea, Ltd. — Product Code PHZ

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.