FDA 510(k)

Nexus大眾自愈式

K 號：K191548 · 2019-10-11

決定日期2019-10-11

產品代碼EMA

諮詢委員會DE

決定相當於

器材摘要

Nexus Universal Self-Cure is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation. It received FDA 510(k) clearance on 2019-10-11 under 510(k) number K191548. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nexus Universal Self-Cure?

Nexus Universal Self-Cure is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Kerr Corporation. The 510(k) number is K191548.

When did Nexus Universal Self-Cure receive FDA 510(k) clearance?

Nexus Universal Self-Cure received FDA 510(k) clearance on 2019-10-11, under 510(k) number K191548.

Who is the listed applicant for Nexus Universal Self-Cure?

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

What is the FDA product code for Nexus Universal Self-Cure?

The FDA product code for Nexus Universal Self-Cure is EMA.

其他以 Kerr Corporation 為申請人之記錄

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相關器械（代碼：EMA）

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。

K262983EsTemp 偽裝體Spident Co., Ltd.K254201任何-瓷Mediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak K261166DIA-CEMDiaDent Group International K254109G-CEM 大眾化GC America, Inc.K253337REGEN 生物活性水泥Inter-Med, Inc.

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