FDA 510(k)

牙科疼痛消除器

K号: K193570 · 2020-01-17

决定日期2020-01-17

产品代码LWM

决定实质等同

器械摘要

Dental Pain Eraser is the device name listed in this FDA 510(k) record. The listed applicant is Synapse Dental. It received FDA 510(k) clearance on 2020-01-17 under 510(k) number K193570. The device is classified under product code LWM. FDA Decision: Substantially Equivalent.

常见问题

What is the Dental Pain Eraser?

Dental Pain Eraser is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Synapse Dental. The 510(k) number is K193570.

When did Dental Pain Eraser receive FDA 510(k) clearance?

Dental Pain Eraser received FDA 510(k) clearance on 2020-01-17, under 510(k) number K193570.

Who is the listed applicant for Dental Pain Eraser?

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

What is the FDA product code for Dental Pain Eraser?

The FDA product code for Dental Pain Eraser is LWM.

列明Synapse Dental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。

K192429牙科疼痛消除器

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。