Cleared Traditional

Fenom Pro

K213611 · Caire Diagnostics, Inc. · Chemistry
Jun 2023
Decision
569d
Days
Class 2
Risk

About This 510(k) Submission

K213611 is an FDA 510(k) clearance for the Fenom Pro, a System, Test, Breath Nitric Oxide (Class II — Special Controls, product code MXA), submitted by Caire Diagnostics, Inc. (Pleasanton, US). The FDA issued a Cleared decision on June 7, 2023, 569 days after receiving the submission on November 15, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3080.

Submission Details

510(k) Number K213611 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2021
Decision Date June 07, 2023
Days to Decision 569 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