Vivatmo pro-S— 510(k) K243926

Substantially Equivalent

Bosch Healthcare Solutions GmbH

FDA 510(k) clearance K243926 for Vivatmo pro-S, Substantially Equivalent on 2025-09-11. Applicant: Bosch Healthcare Solutions GmbH. Device class: 2.

Clearance details

Applicant: Bosch Healthcare Solutions GmbH
Product code: Code MXA
Device class: Class 2
Regulation: 21 CFR 862.3080
Advisory panel: Clinical Toxicology
Date received: 2024-12-20
Decision date: 2025-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waiblingen, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.