FDA 510(k)

Icare ic200

K号: K190316 · 2020-01-14

决定日期2020-01-14

产品代码HKY

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决定实质等同

器械摘要

Icare ic200 is the device name listed in this FDA 510(k) record. The listed applicant is Icare Finland OY. It received FDA 510(k) clearance on 2020-01-14 under 510(k) number K190316. 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 Icare ic200?

Icare ic200 is a medical device that received FDA 510(k) clearance on 2020-01-14. The listed applicant is Icare Finland OY. The 510(k) number is K190316.

When did Icare ic200 receive FDA 510(k) clearance?

Icare ic200 received FDA 510(k) clearance on 2020-01-14, under 510(k) number K190316.

Who is the listed applicant for Icare ic200?

The FDA 510(k) record lists Icare Finland OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Icare ic200?

The FDA product code for Icare ic200 is HKY.

列明Icare Finland OY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。

K241447iCare ST500（TA04）K220852iCare IC200 K211355iCare HOME2 K200966Icare HOME 眼压计 K163343Icare HOME 眼压计 K153694Icare ic100

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。