FDA 510(k)

EVO 700系列高速手持式工具

K 號：K232243 · 2023-08-23

決定日期2023-08-23

產品代碼EFB

諮詢委員會DE

決定相當於

器材摘要

EVO 700 series high speed handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Ttbio Corp.. It received FDA 510(k) clearance on 2023-08-23 under 510(k) number K232243. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EVO 700 series high speed handpiece?

EVO 700 series high speed handpiece is a medical device that received FDA 510(k) clearance on 2023-08-23. The listed applicant is Ttbio Corp.. The 510(k) number is K232243.

When did EVO 700 series high speed handpiece receive FDA 510(k) clearance?

EVO 700 series high speed handpiece received FDA 510(k) clearance on 2023-08-23, under 510(k) number K232243.

Who is the listed applicant for EVO 700 series high speed handpiece?

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

What is the FDA product code for EVO 700 series high speed handpiece?

The FDA product code for EVO 700 series high speed handpiece is EFB.

其他以 Ttbio Corp. 為申請人之記錄

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相關器械（代碼：EFB）

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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