FDA 510(k)

Videa 牙科助手

K号: K232384 · 2023-12-15

决定日期2023-12-15

产品代码MYN

咨询委员会RA

决定实质等同

器械摘要

Videa Dental Assist is the device name listed in this FDA 510(k) record. The listed applicant is Videahealth, Inc.. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K232384. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Videa Dental Assist?

Videa Dental Assist is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Videahealth, Inc.. The 510(k) number is K232384.

When did Videa Dental Assist receive FDA 510(k) clearance?

Videa Dental Assist received FDA 510(k) clearance on 2023-12-15, under 510(k) number K232384.

Who is the listed applicant for Videa Dental Assist?

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

What is the FDA product code for Videa Dental Assist?

The FDA product code for Videa Dental Assist is MYN.

列明Videahealth, Inc.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。

K251002Videa 牙科人工智能 K223296Videa牙周辅助 K213795Videa 牙菌斑辅助设备

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。