1L Flexoval® 瓶装吸入用无菌水
K号: K223551 · 2023-08-03
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申请人Hometa, Inc.
决定日期2023-08-03
产品代码BTT
咨询委员会AN
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决定实质等同
器械摘要
Sterile Water for Inhalation in 1L Flexoval ® bottles. is the device name listed in this FDA 510(k) record. The listed applicant is Hometa, Inc.. It received FDA 510(k) clearance on 2023-08-03 under 510(k) number K223551. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Sterile Water for Inhalation in 1L Flexoval ® bottles.?
Sterile Water for Inhalation in 1L Flexoval ® bottles. is a medical device that received FDA 510(k) clearance on 2023-08-03. The listed applicant is Hometa, Inc.. The 510(k) number is K223551.
When did Sterile Water for Inhalation in 1L Flexoval ® bottles. receive FDA 510(k) clearance?
Sterile Water for Inhalation in 1L Flexoval ® bottles. received FDA 510(k) clearance on 2023-08-03, under 510(k) number K223551.
Who is the listed applicant for Sterile Water for Inhalation in 1L Flexoval ® bottles.?
The FDA 510(k) record lists Hometa, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sterile Water for Inhalation in 1L Flexoval ® bottles.?
The FDA product code for Sterile Water for Inhalation in 1L Flexoval ® bottles. is BTT.
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相关器械（代码：BTT）
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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