FDA 510(k)

TECHFIT 診斷模型

K 號：K222577 · 2023-01-06

決定日期2023-01-06

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

TECHFIT Diagnostic Models is the device name listed in this FDA 510(k) record. The listed applicant is Techfit Digital Surgery, Inc.. It received FDA 510(k) clearance on 2023-01-06 under 510(k) number K222577. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TECHFIT Diagnostic Models?

TECHFIT Diagnostic Models is a medical device that received FDA 510(k) clearance on 2023-01-06. The listed applicant is Techfit Digital Surgery, Inc.. The 510(k) number is K222577.

When did TECHFIT Diagnostic Models receive FDA 510(k) clearance?

TECHFIT Diagnostic Models received FDA 510(k) clearance on 2023-01-06, under 510(k) number K222577.

Who is the listed applicant for TECHFIT Diagnostic Models?

The FDA 510(k) record lists Techfit Digital Surgery, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TECHFIT Diagnostic Models?

The FDA product code for TECHFIT Diagnostic Models is LLZ.

其他以 Techfit Digital Surgery, Inc. 為申請人之記錄

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：LLZ）

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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