FDA 510(k)

BOMEDENT尖定位器，WISMY尖定位器

K号: K203836 · 2021-03-30

申请人Changzhou Bomedent Medical Technology Co.,Ltd

决定日期2021-03-30

产品代码LQY

决定实质等同

器械摘要

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.

常见问题

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.

列明Changzhou Bomedent Medical Technology Co.,Ltd为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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