AIRO 吸引单元（AIRO-01）
K号: K251101 · 2025-04-26
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器械摘要
AIRO Suction Unit (AIRO-01) is the device name listed in this FDA 510(k) record. The listed applicant is Cro, LLC. It received FDA 510(k) clearance on 2025-04-26 under 510(k) number K251101. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the AIRO Suction Unit (AIRO-01)?
AIRO Suction Unit (AIRO-01) is a medical device that received FDA 510(k) clearance on 2025-04-26. The listed applicant is Cro, LLC. The 510(k) number is K251101.
When did AIRO Suction Unit (AIRO-01) receive FDA 510(k) clearance?
AIRO Suction Unit (AIRO-01) received FDA 510(k) clearance on 2025-04-26, under 510(k) number K251101.
Who is the listed applicant for AIRO Suction Unit (AIRO-01)?
The FDA 510(k) record lists Cro, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AIRO Suction Unit (AIRO-01)?
The FDA product code for AIRO Suction Unit (AIRO-01) is BTA.
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。
相关器械（代码：BTA）
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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