Cleared Traditional

wheezo WheezeRate Detector

K202062 · Respiri Limited · Anesthesiology

Mar 2021

Decision

227d

Days

Class 2

Risk

About This 510(k) Submission

K202062 is an FDA 510(k) clearance for the wheezo WheezeRate Detector, a Abnormal Breath Sound Device (Class II — Special Controls, product code PHZ), submitted by Respiri Limited (Melbourne, AU). The FDA issued a Cleared decision on March 11, 2021, 227 days after receiving the submission on July 27, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1900.

Submission Details

510(k) Number	K202062 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 27, 2020
Decision Date	March 11, 2021
Days to Decision	227 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.