FDA 510(k)

簽名正畸系統

K 號：K183542 · 2019-01-02

決定日期2019-01-02

產品代碼NJM

諮詢委員會DE

決定相當於

器材摘要

Signature Orthodontic System is the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthodontics. It received FDA 510(k) clearance on 2019-01-02 under 510(k) number K183542. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Signature Orthodontic System?

Signature Orthodontic System is a medical device that received FDA 510(k) clearance on 2019-01-02. The listed applicant is Signature Orthodontics. The 510(k) number is K183542.

When did Signature Orthodontic System receive FDA 510(k) clearance?

Signature Orthodontic System received FDA 510(k) clearance on 2019-01-02, under 510(k) number K183542.

Who is the listed applicant for Signature Orthodontic System?

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

What is the FDA product code for Signature Orthodontic System?

The FDA product code for Signature Orthodontic System is NJM.

其他以 Signature Orthodontics 為申請人之記錄

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K181271簽名正畸系統

相關器械（代碼：NJM）

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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