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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 a medical device manufactured by Bosch Healthcare Solutions GmbH. It received FDA 510(k) clearance on 2025-09-11 under approval 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. It is manufactured by Bosch Healthcare Solutions GmbH. The 510(k) number is K243926.

When was Vivatmo pro-S approved by the FDA?

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

What company makes Vivatmo pro-S?

Vivatmo pro-S is manufactured by Bosch Healthcare Solutions GmbH.

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

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

Other Devices by Bosch Healthcare Solutions GmbH

K233775Vivatmo pro

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K170983NIOX VEROCircassia AB K182874Fenom Pro Nitric Oxide TestSpirosure, Inc. K203695NObreath®Bedfont Scientific, Ltd. K213611Fenom ProCaire Diagnostics, Inc. K233775Vivatmo proBosch Healthcare Solutions GmbH K251674Fenom Flo™ FeNO Monitoring SystemMgc Diagnostics Corporation

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.

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