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FDA 510(k)

蒙特布蘭特板系統

K 號：K243368 · 2025-06-04

申請人Medifield Medical Co., Ltd.
決定日期2025-06-04
產品代碼HRS
諮詢委員會或
決定相當於

器材摘要

Montblanc Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Medifield Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-06-04 under 510(k) number K243368. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Montblanc Plate System?

Montblanc Plate System is a medical device that received FDA 510(k) clearance on 2025-06-04. The listed applicant is Medifield Medical Co., Ltd.. The 510(k) number is K243368.

When did Montblanc Plate System receive FDA 510(k) clearance?

Montblanc Plate System received FDA 510(k) clearance on 2025-06-04, under 510(k) number K243368.

Who is the listed applicant for Montblanc Plate System?

The FDA 510(k) record lists Medifield Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Montblanc Plate System?

The FDA product code for Montblanc Plate System is HRS.

相關臨床試驗

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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相關器械（代碼：HRS）

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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