FDA 510(k)

智能胸腔

K 號：K232410 · 2024-05-10

申請人Milvue

決定日期2024-05-10

產品代碼QFM

諮詢委員會RA

決定相當於

器材摘要

SmartChest is the device name listed in this FDA 510(k) record. The listed applicant is Milvue. It received FDA 510(k) clearance on 2024-05-10 under 510(k) number K232410. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SmartChest?

SmartChest is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is Milvue. The 510(k) number is K232410.

When did SmartChest receive FDA 510(k) clearance?

SmartChest received FDA 510(k) clearance on 2024-05-10, under 510(k) number K232410.

Who is the listed applicant for SmartChest?

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

What is the FDA product code for SmartChest?

The FDA product code for SmartChest is QFM.

其他以 Milvue 為申請人之記錄

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K242171TechCare 輕傷治療設備

相關器械（代碼：QFM）

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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