Cleared Traditional

NObreath?

K203695 · Bedfont Scientific, Ltd. · Chemistry
Dec 2021
Decision
364d
Days
Class 2
Risk

About This 510(k) Submission

K203695 is an FDA 510(k) clearance for the NObreath?, a System, Test, Breath Nitric Oxide (Class II — Special Controls, product code MXA), submitted by Bedfont Scientific, Ltd. (Maidstone, Kent, GB). The FDA issued a Cleared decision on December 17, 2021, 364 days after receiving the submission on December 18, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3080.

Submission Details

510(k) Number K203695 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2020
Decision Date December 17, 2021
Days to Decision 364 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