FDA 510(k)

霍夫曼LRF系統

K 號：K253202 · 2025-12-19

決定日期2025-12-19

產品代碼KTT

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決定相當於

器材摘要

Hoffmann LRF System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K253202. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hoffmann LRF System?

Hoffmann LRF System is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Stryker GmbH. The 510(k) number is K253202.

When did Hoffmann LRF System receive FDA 510(k) clearance?

Hoffmann LRF System received FDA 510(k) clearance on 2025-12-19, under 510(k) number K253202.

Who is the listed applicant for Hoffmann LRF System?

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

What is the FDA product code for Hoffmann LRF System?

The FDA product code for Hoffmann LRF System is KTT.

其他以 Stryker GmbH 為申請人之記錄

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相關器械（代碼：KTT）

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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