Cleared Traditional

Fenom Pro Nitric Oxide Test

K182874 · Spirosure, Inc. · Chemistry
Feb 2019
Decision
124d
Days
Class 2
Risk

About This 510(k) Submission

K182874 is an FDA 510(k) clearance for the Fenom Pro Nitric Oxide Test, a System, Test, Breath Nitric Oxide (Class II — Special Controls, product code MXA), submitted by Spirosure, Inc. (Pleasanton, US). The FDA issued a Cleared decision on February 13, 2019, 124 days after receiving the submission on October 12, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3080.

Submission Details

510(k) Number K182874 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 2018
Decision Date February 13, 2019
Days to Decision 124 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MXA — System, Test, Breath Nitric Oxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3080