Cleared Traditional

Aluna

K193311 · Knox Medical Diagnostics, Inc. · Anesthesiology

Mar 2020

Decision

117d

Days

Class 2

Risk

About This 510(k) Submission

K193311 is an FDA 510(k) clearance for the Aluna, a Meter, Peak Flow, Spirometry (Class II — Special Controls, product code BZH), submitted by Knox Medical Diagnostics, Inc. (San Francisco, US). The FDA issued a Cleared decision on March 25, 2020, 117 days after receiving the submission on November 29, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1860.

Submission Details

510(k) Number	K193311 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 29, 2019
Decision Date	March 25, 2020
Days to Decision	117 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF