FDA 510(k)

NFC-600 自动便携式视网膜照相机

K号: K210197 · 2021-04-13

决定日期2021-04-13

产品代码HKI

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决定实质等同

器械摘要

NFC-600 Automated Portable Retinal Camera is the device name listed in this FDA 510(k) record. The listed applicant is Crystalvue Medical Corporation. It received FDA 510(k) clearance on 2021-04-13 under 510(k) number K210197. 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 NFC-600 Automated Portable Retinal Camera?

NFC-600 Automated Portable Retinal Camera is a medical device that received FDA 510(k) clearance on 2021-04-13. The listed applicant is Crystalvue Medical Corporation. The 510(k) number is K210197.

When did NFC-600 Automated Portable Retinal Camera receive FDA 510(k) clearance?

NFC-600 Automated Portable Retinal Camera received FDA 510(k) clearance on 2021-04-13, under 510(k) number K210197.

Who is the listed applicant for NFC-600 Automated Portable Retinal Camera?

The FDA 510(k) record lists Crystalvue Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NFC-600 Automated Portable Retinal Camera?

The FDA product code for NFC-600 Automated Portable Retinal Camera is HKI.

列明Crystalvue Medical 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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