AEYE-DS
K号: K221183 · 2022-11-10
广告
决定日期2022-11-10
产品代码PIB
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
AEYE-DS is the device name listed in this FDA 510(k) record. The listed applicant is Aeye Health, Inc.. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K221183. The device is classified under product code PIB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the AEYE-DS?
AEYE-DS is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Aeye Health, Inc.. The 510(k) number is K221183.
When did AEYE-DS receive FDA 510(k) clearance?
AEYE-DS received FDA 510(k) clearance on 2022-11-10, under 510(k) number K221183.
Who is the listed applicant for AEYE-DS?
The FDA 510(k) record lists Aeye Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AEYE-DS?
The FDA product code for AEYE-DS is PIB.
列明Aeye Health, Inc.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：PIB）
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。
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