Keeler TonoCare眼压计
K号: K181143 · 2019-02-08
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决定日期2019-02-08
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
Keeler TonoCare Tonometer is the device name listed in this FDA 510(k) record. The listed applicant is Keeler Instruments, Inc.. It received FDA 510(k) clearance on 2019-02-08 under 510(k) number K181143. 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 Keeler TonoCare Tonometer?
Keeler TonoCare Tonometer is a medical device that received FDA 510(k) clearance on 2019-02-08. The listed applicant is Keeler Instruments, Inc.. The 510(k) number is K181143.
When did Keeler TonoCare Tonometer receive FDA 510(k) clearance?
Keeler TonoCare Tonometer received FDA 510(k) clearance on 2019-02-08, under 510(k) number K181143.
Who is the listed applicant for Keeler TonoCare Tonometer?
The FDA 510(k) record lists Keeler Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Keeler TonoCare Tonometer?
The FDA product code for Keeler TonoCare 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。
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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