KLAXON (TWIST); KLAXON (TWIST R)
K号: K250748 · 2025-04-11
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决定日期2025-04-11
产品代码ITI
咨询委员会PM
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决定实质等同
器械摘要
KLAXON (TWIST); KLAXON (TWIST R) is the device name listed in this FDA 510(k) record. The listed applicant is Klaxon-Mobility GmbH. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K250748. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the KLAXON (TWIST); KLAXON (TWIST R)?
KLAXON (TWIST); KLAXON (TWIST R) is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Klaxon-Mobility GmbH. The 510(k) number is K250748.
When did KLAXON (TWIST); KLAXON (TWIST R) receive FDA 510(k) clearance?
KLAXON (TWIST); KLAXON (TWIST R) received FDA 510(k) clearance on 2025-04-11, under 510(k) number K250748.
Who is the listed applicant for KLAXON (TWIST); KLAXON (TWIST R)?
The FDA 510(k) record lists Klaxon-Mobility GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for KLAXON (TWIST); KLAXON (TWIST R)?
The FDA product code for KLAXON (TWIST); KLAXON (TWIST R) is ITI.
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。
列明Klaxon-Mobility GmbH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：ITI）
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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