FDA 510(k)

DynaFlex

K 號：K190583 · 2019-06-27

決定日期2019-06-27

產品代碼NXC

諮詢委員會DE

決定相當於

器材摘要

DynaFlex is the device name listed in this FDA 510(k) record. The listed applicant is Dyna Flex. It received FDA 510(k) clearance on 2019-06-27 under 510(k) number K190583. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DynaFlex?

DynaFlex is a medical device that received FDA 510(k) clearance on 2019-06-27. The listed applicant is Dyna Flex. The 510(k) number is K190583.

When did DynaFlex receive FDA 510(k) clearance?

DynaFlex received FDA 510(k) clearance on 2019-06-27, under 510(k) number K190583.

Who is the listed applicant for DynaFlex?

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

What is the FDA product code for DynaFlex?

The FDA product code for DynaFlex is NXC.

其他以 Dyna Flex 為申請人之記錄

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K230225DynaFlex 清晰牙弓絲與按鈕

相關器械（代碼：NXC）

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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