FSYX 眼压调节泵
K号: K252455 · 2026-04-30
广告
决定日期2026-04-30
产品代码QQJ
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
FSYX Ocular Pressure Adjusting Pump is the device name listed in this FDA 510(k) record. The listed applicant is Balance Ophthalmics, Inc.. It received FDA 510(k) clearance on 2026-04-30 under 510(k) number K252455. The device is classified under product code QQJ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the FSYX Ocular Pressure Adjusting Pump?
FSYX Ocular Pressure Adjusting Pump is a medical device that received FDA 510(k) clearance on 2026-04-30. The listed applicant is Balance Ophthalmics, Inc.. The 510(k) number is K252455.
When did FSYX Ocular Pressure Adjusting Pump receive FDA 510(k) clearance?
FSYX Ocular Pressure Adjusting Pump received FDA 510(k) clearance on 2026-04-30, under 510(k) number K252455.
Who is the listed applicant for FSYX Ocular Pressure Adjusting Pump?
The FDA 510(k) record lists Balance Ophthalmics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FSYX Ocular Pressure Adjusting Pump?
The FDA product code for FSYX Ocular Pressure Adjusting Pump is QQJ.
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。
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