BOMEDENT Apex locator, WISMY Apex locator
K-Number: K203836 · 2021-03-30
Decision Date2021-03-30
Product CodeLQY
DecisionSubstantially Equivalent
Device Summary
BOMEDENT Apex locator, WISMY Apex locator is a medical device manufactured by Changzhou Bomedent Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2021-03-30 under approval number K203836. The device is classified under product code LQY. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by Changzhou Bomedent Medical Technology Co.,Ltd. The 510(k) number is K203836.
When was BOMEDENT Apex locator, WISMY Apex locator approved by the FDA?
BOMEDENT Apex locator, WISMY Apex locator received FDA 510(k) clearance on 2021-03-30, under approval number K203836.
What company makes BOMEDENT Apex locator, WISMY Apex locator?
BOMEDENT Apex locator, WISMY Apex locator is manufactured by Changzhou Bomedent Medical Technology Co.,Ltd.
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.
Other Devices by Changzhou Bomedent Medical Technology Co.,Ltd
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.