FDA 510(k)

压平眼压计 HT-5000

K号: K232143 · 2023-10-23

决定日期2023-10-23

产品代码HKY

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决定实质等同

器械摘要

Applanation Tonometer HT-5000 is the device name listed in this FDA 510(k) record. The listed applicant is Huvitz Co., Ltd.. It received FDA 510(k) clearance on 2023-10-23 under 510(k) number K232143. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Applanation Tonometer HT-5000?

Applanation Tonometer HT-5000 is a medical device that received FDA 510(k) clearance on 2023-10-23. The listed applicant is Huvitz Co., Ltd.. The 510(k) number is K232143.

When did Applanation Tonometer HT-5000 receive FDA 510(k) clearance?

Applanation Tonometer HT-5000 received FDA 510(k) clearance on 2023-10-23, under 510(k) number K232143.

Who is the listed applicant for Applanation Tonometer HT-5000?

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

What is the FDA product code for Applanation Tonometer HT-5000?

The FDA product code for Applanation Tonometer HT-5000 is HKY.

列明Huvitz 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。

K202097眼底相机 K191615Huvitz 成像系统 K161829Huvitz 成像系统

官方来源

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