Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Vivatmo pro-S

K-Number: K243926 · 2025-09-11

ApplicantBosch Healthcare Solutions GmbH
Decision Date2025-09-11
Product CodeMXA
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Vivatmo pro-S is the device name listed in this FDA 510(k) record. The listed applicant is Bosch Healthcare Solutions GmbH. It received FDA 510(k) clearance on 2025-09-11 under 510(k) number K243926. The device is classified under product code MXA. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vivatmo pro-S?

Vivatmo pro-S is a medical device that received FDA 510(k) clearance on 2025-09-11. The listed applicant is Bosch Healthcare Solutions GmbH. The 510(k) number is K243926.

When did Vivatmo pro-S receive FDA 510(k) clearance?

Vivatmo pro-S received FDA 510(k) clearance on 2025-09-11, under 510(k) number K243926.

Who is the listed applicant for Vivatmo pro-S?

The FDA 510(k) record lists Bosch Healthcare Solutions GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vivatmo pro-S?

The FDA product code for Vivatmo pro-S is MXA.

Other records listing Bosch Healthcare Solutions GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233775Vivatmo pro

Related Devices (Code: MXA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251674Fenom Flo™ FeNO Monitoring SystemMgc Diagnostics CorporationK233775Vivatmo proBosch Healthcare Solutions GmbHK213611Fenom ProCaire Diagnostics, Inc.K203695NObreath®Bedfont Scientific, Ltd.K182874Fenom Pro Nitric Oxide TestSpirosure, Inc.K170983NIOX VEROCircassia AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑