FDA 510(k)

牙科電動機 iRoot Pro

K 號：K191276 · 2020-06-30

申請人Changzhou Bomedent Medical Technology Co.,Ltd

決定日期2020-06-30

產品代碼EKX

諮詢委員會DE

決定相當於

器材摘要

Dental Electrical Motor iRoot Pro is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Bomedent Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2020-06-30 under 510(k) number K191276. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dental Electrical Motor iRoot Pro?

Dental Electrical Motor iRoot Pro is a medical device that received FDA 510(k) clearance on 2020-06-30. The listed applicant is Changzhou Bomedent Medical Technology Co.,Ltd. The 510(k) number is K191276.

When did Dental Electrical Motor iRoot Pro receive FDA 510(k) clearance?

Dental Electrical Motor iRoot Pro received FDA 510(k) clearance on 2020-06-30, under 510(k) number K191276.

Who is the listed applicant for Dental Electrical Motor iRoot Pro?

The FDA 510(k) record lists Changzhou Bomedent Medical Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Electrical Motor iRoot Pro?

The FDA product code for Dental Electrical Motor iRoot Pro is EKX.

其他以 Changzhou Bomedent Medical Technology Co.,Ltd 為申請人之記錄

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相關器械（代碼：EKX）

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