FDA 510(k)

Vivatmo pro-S

K 號：K243926 · 2025-09-11

決定日期2025-09-11

產品代碼MXA

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決定相當於

器材摘要

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.

常見問題

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.

其他以 Bosch Healthcare Solutions GmbH 為申請人之記錄

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K233775Vivatmo pro

相關器械（代碼：MXA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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