Cleared Traditional

Vivatmo pro

K233775 · Bosch Healthcare Solutions GmbH · Chemistry
Feb 2024
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K233775 is an FDA 510(k) clearance for the Vivatmo pro, 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 February 22, 2024, 90 days after receiving the submission on November 24, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3080.

Submission Details

510(k) Number K233775 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2023
Decision Date February 22, 2024
Days to Decision 90 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