KALA MINI 2.0 (KALA-04)
K号: K251781 · 2025-09-04
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决定日期2025-09-04
产品代码OHS
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
KALA MINI 2.0 (KALA-04) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K251781. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the KALA MINI 2.0 (KALA-04)?
KALA MINI 2.0 (KALA-04) is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K251781.
When did KALA MINI 2.0 (KALA-04) receive FDA 510(k) clearance?
KALA MINI 2.0 (KALA-04) received FDA 510(k) clearance on 2025-09-04, under 510(k) number K251781.
Who is the listed applicant for KALA MINI 2.0 (KALA-04)?
FDA 510(k)记录将深圳凯研医疗设备有限公司列为申请人。这本身并不足以确立该设备制造商的身份。
What is the FDA product code for KALA MINI 2.0 (KALA-04)?
The FDA product code for KALA MINI 2.0 (KALA-04) is OHS.
列明Shenzhen Kaiyan Medical Equipment Co., Ltd.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：OHS）
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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