FDA 510(k)

AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA

K号: K253039 · 2025-11-07

决定日期2025-11-07

产品代码HKX

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决定实质等同

器械摘要

AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Corporation. It received FDA 510(k) clearance on 2025-11-07 under 510(k) number K253039. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA?

AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA is a medical device that received FDA 510(k) clearance on 2025-11-07. The listed applicant is Topcon Corporation. The 510(k) number is K253039.

When did AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA receive FDA 510(k) clearance?

AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA received FDA 510(k) clearance on 2025-11-07, under 510(k) number K253039.

Who is the listed applicant for AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA?

FDA 510(k)记录显示Topcon Corporation为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA?

The FDA product code for AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA is HKX.

列明Topcon Corporation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。

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