眼内压计 EASYTON
K号: K190382 · 2019-12-06
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决定日期2019-12-06
产品代码HKX
咨询委员会OP
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决定实质等同
器械摘要
Intraocular Pressure Tonometer EASYTON is the device name listed in this FDA 510(k) record. The listed applicant is Company Elamed. It received FDA 510(k) clearance on 2019-12-06 under 510(k) number K190382. 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 Intraocular Pressure Tonometer EASYTON?
Intraocular Pressure Tonometer EASYTON is a medical device that received FDA 510(k) clearance on 2019-12-06. The listed applicant is Company Elamed. The 510(k) number is K190382.
When did Intraocular Pressure Tonometer EASYTON receive FDA 510(k) clearance?
Intraocular Pressure Tonometer EASYTON received FDA 510(k) clearance on 2019-12-06, under 510(k) number K190382.
Who is the listed applicant for Intraocular Pressure Tonometer EASYTON?
The FDA 510(k) record lists Company Elamed as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Intraocular Pressure Tonometer EASYTON?
The FDA product code for Intraocular Pressure Tonometer EASYTON is HKX.
相关临床试验
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。
相关器械（代码：HKX）
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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官方来源
在 FDA 数据库中查看 →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。
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