FDA 510(k)

TDS (TECHWIN DENTAL SYSTEM)

K号: K231932 · 2024-08-20

决定日期2024-08-20

产品代码NHA

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决定实质等同

器械摘要

TDS (TECHWIN DENTAL SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Techwin Co., Ltd.. It received FDA 510(k) clearance on 2024-08-20 under 510(k) number K231932. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TDS (TECHWIN DENTAL SYSTEM)?

TDS (TECHWIN DENTAL SYSTEM) is a medical device that received FDA 510(k) clearance on 2024-08-20. The listed applicant is Techwin Co., Ltd.. The 510(k) number is K231932.

When did TDS (TECHWIN DENTAL SYSTEM) receive FDA 510(k) clearance?

TDS (TECHWIN DENTAL SYSTEM) received FDA 510(k) clearance on 2024-08-20, under 510(k) number K231932.

Who is the listed applicant for TDS (TECHWIN DENTAL SYSTEM)?

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

What is the FDA product code for TDS (TECHWIN DENTAL SYSTEM)?

The FDA product code for TDS (TECHWIN DENTAL SYSTEM) is NHA.

列明Techwin 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。

K231913T-FIT

相关器械（代码：NHA）

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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官方来源

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