AISAP 心脏 V1.0
K号: K234141 · 2024-08-01
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器械摘要
AISAP Cardio V1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Aisap. It received FDA 510(k) clearance on 2024-08-01 under 510(k) number K234141. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the AISAP Cardio V1.0?
AISAP Cardio V1.0 is a medical device that received FDA 510(k) clearance on 2024-08-01. The listed applicant is Aisap. The 510(k) number is K234141.
When did AISAP Cardio V1.0 receive FDA 510(k) clearance?
AISAP Cardio V1.0 received FDA 510(k) clearance on 2024-08-01, under 510(k) number K234141.
Who is the listed applicant for AISAP Cardio V1.0?
The FDA 510(k) record lists Aisap as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AISAP Cardio V1.0?
The FDA product code for AISAP Cardio V1.0 is POK.
相关临床试验
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相关器械（代码：POK）
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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