Tono Vue 非接触式眼压计
K号: K180820 · 2018-12-14
广告
决定日期2018-12-14
产品代码HKX
咨询委员会OP
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
Tono Vue Non-Contact Tonometer 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 2018-12-14 under 510(k) number K180820. 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 Tono Vue Non-Contact Tonometer?
Tono Vue Non-Contact Tonometer is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is Crystalvue Medical Corporation. The 510(k) number is K180820.
When did Tono Vue Non-Contact Tonometer receive FDA 510(k) clearance?
Tono Vue Non-Contact Tonometer received FDA 510(k) clearance on 2018-12-14, under 510(k) number K180820.
Who is the listed applicant for Tono Vue Non-Contact Tonometer?
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 Tono Vue Non-Contact Tonometer?
The FDA product code for Tono Vue Non-Contact Tonometer 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。
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。
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。
K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATopcon CorporationK223739VS台式眼压计Medimaging Integrated Solution, Inc.K190382眼内压计 EASYTONCompany ElamedK181260MiiS Horus Scope DPT 100Medimaging Integrated Solution, Inc (Miis)K181143Keeler TonoCare眼压计Keeler Instruments, Inc.K162067VX130 眼科诊断设备Luneau Sas
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。
广告