FDA 510(k)

TechCare 輕傷治療設備

K 號：K242171 · 2025-01-17

申請人Milvue

決定日期2025-01-17

產品代碼QBS

諮詢委員會RA

決定相當於

器材摘要

TechCare Trauma is the device name listed in this FDA 510(k) record. The listed applicant is Milvue. It received FDA 510(k) clearance on 2025-01-17 under 510(k) number K242171. The device is classified under product code QBS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TechCare Trauma?

TechCare Trauma is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is Milvue. The 510(k) number is K242171.

When did TechCare Trauma receive FDA 510(k) clearance?

TechCare Trauma received FDA 510(k) clearance on 2025-01-17, under 510(k) number K242171.

Who is the listed applicant for TechCare Trauma?

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 TechCare Trauma?

The FDA product code for TechCare Trauma is QBS.

其他以 Milvue 為申請人之記錄

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K232410智能胸腔

相關器械（代碼：QBS）

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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