FDA 510(k)

非散列视网膜相机 NW500

K号: K221111 · 2022-08-29

决定日期2022-08-29

产品代码HKI

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决定实质等同

器械摘要

Non-Mydriatic Retinal Camera NW500 is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Corporation. It received FDA 510(k) clearance on 2022-08-29 under 510(k) number K221111. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Non-Mydriatic Retinal Camera NW500?

Non-Mydriatic Retinal Camera NW500 is a medical device that received FDA 510(k) clearance on 2022-08-29. The listed applicant is Topcon Corporation. The 510(k) number is K221111.

When did Non-Mydriatic Retinal Camera NW500 receive FDA 510(k) clearance?

Non-Mydriatic Retinal Camera NW500 received FDA 510(k) clearance on 2022-08-29, under 510(k) number K221111.

Who is the listed applicant for Non-Mydriatic Retinal Camera NW500?

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 Non-Mydriatic Retinal Camera NW500?

The FDA product code for Non-Mydriatic Retinal Camera NW500 is HKI.

列明Topcon Corporation为申报人的其他记录

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