Cleared Traditional

Vivatmo pro-S

K243926 · Bosch Healthcare Solutions GmbH · Chemistry
Sep 2025
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K243926 is an FDA 510(k) clearance for the Vivatmo pro-S, a System, Test, Breath Nitric Oxide (Class II — Special Controls, product code MXA), submitted by Bosch Healthcare Solutions GmbH (Waiblingen, DE). The FDA issued a Cleared decision on September 11, 2025, 265 days after receiving the submission on December 20, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3080.

Submission Details

510(k) Number K243926 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2024
Decision Date September 11, 2025
Days to Decision 265 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