FDA 510(k)

BOMEDENT Apex 定位器，WISMY Apex 定位器

K 號：K203836 · 2021-03-30

申請人Changzhou Bomedent Medical Technology Co.,Ltd

決定日期2021-03-30

產品代碼LQY

決定相當於

器材摘要

BOMEDENT Apex locator, WISMY Apex locator 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 2021-03-30 under 510(k) number K203836. The device is classified under product code LQY. FDA Decision: Substantially Equivalent.

常見問題

What is the BOMEDENT Apex locator, WISMY Apex locator?

BOMEDENT Apex locator, WISMY Apex locator is a medical device that received FDA 510(k) clearance on 2021-03-30. The listed applicant is Changzhou Bomedent Medical Technology Co.,Ltd. The 510(k) number is K203836.

When did BOMEDENT Apex locator, WISMY Apex locator receive FDA 510(k) clearance?

BOMEDENT Apex locator, WISMY Apex locator received FDA 510(k) clearance on 2021-03-30, under 510(k) number K203836.

Who is the listed applicant for BOMEDENT Apex locator, WISMY Apex locator?

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 BOMEDENT Apex locator, WISMY Apex locator?

The FDA product code for BOMEDENT Apex locator, WISMY Apex locator is LQY.

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：LQY）

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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