Cleared Traditional

SONOSENTRY

K131285 · Isonea, Ltd. · Anesthesiology

Aug 2014

Decision

470d

Days

Class 2

Risk

About This 510(k) Submission

K131285 is an FDA 510(k) clearance for the SONOSENTRY, a Abnormal Breath Sound Device (Class II — Special Controls, product code PHZ), submitted by Isonea, Ltd. (Carlsbad, US). The FDA issued a Cleared decision on August 19, 2014, 470 days after receiving the submission on May 6, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1900.

Submission Details

510(k) Number	K131285 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 2013
Decision Date	August 19, 2014
Days to Decision	470 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	PHZ — Abnormal Breath Sound Device
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.1900
Definition	The Device Is Intended To Measure Abnormal Breath Sound, Such As Wheeze, Rhonchi, And Whistling.