Aqua Naina 无菌盐水溶液
K号: K193441 · 2020-05-26
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决定日期2020-05-26
产品代码LPN
咨询委员会OP
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决定实质等同
器械摘要
Aqua Naina Sterile Saline Solution is the device name listed in this FDA 510(k) record. The listed applicant is Chemtex USA, Inc.. It received FDA 510(k) clearance on 2020-05-26 under 510(k) number K193441. The device is classified under product code LPN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Aqua Naina Sterile Saline Solution?
Aqua Naina Sterile Saline Solution is a medical device that received FDA 510(k) clearance on 2020-05-26. The listed applicant is Chemtex USA, Inc.. The 510(k) number is K193441.
When did Aqua Naina Sterile Saline Solution receive FDA 510(k) clearance?
Aqua Naina Sterile Saline Solution received FDA 510(k) clearance on 2020-05-26, under 510(k) number K193441.
Who is the listed applicant for Aqua Naina Sterile Saline Solution?
The FDA 510(k) record lists Chemtex USA, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Aqua Naina Sterile Saline Solution?
The FDA product code for Aqua Naina Sterile Saline Solution is LPN.
相关临床试验
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列明Chemtex USA, 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：LPN）
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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