FDA 510(k)

超视视野清除系统

K号: K200035 · 2020-05-04

决定日期2020-05-04

产品代码PQM

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决定实质等同

器械摘要

Ultravision Visual Field Clearing System is the device name listed in this FDA 510(k) record. The listed applicant is Alesi Surgical, Ltd.. It received FDA 510(k) clearance on 2020-05-04 under 510(k) number K200035. The device is classified under product code PQM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ultravision Visual Field Clearing System?

Ultravision Visual Field Clearing System is a medical device that received FDA 510(k) clearance on 2020-05-04. The listed applicant is Alesi Surgical, Ltd.. The 510(k) number is K200035.

When did Ultravision Visual Field Clearing System receive FDA 510(k) clearance?

Ultravision Visual Field Clearing System received FDA 510(k) clearance on 2020-05-04, under 510(k) number K200035.

Who is the listed applicant for Ultravision Visual Field Clearing System?

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

What is the FDA product code for Ultravision Visual Field Clearing System?

The FDA product code for Ultravision Visual Field Clearing System is PQM.

列明Alesi Surgical, 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。

K231238Ultravision2™ 系统 K231298Ultravision2™ 系统集成单极 L 型钩（H/S）™K182053Ultravision™ 视野清晰系统 K170178超视视野清除系统

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。