Empulse M90
K号: K242327 · 2024-12-10
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决定日期2024-12-10
产品代码ITI
咨询委员会PM
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器械摘要
Empulse M90 is the device name listed in this FDA 510(k) record. The listed applicant is Concourse Assistive Technology Pty, Ltd.. It received FDA 510(k) clearance on 2024-12-10 under 510(k) number K242327. 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 Empulse M90?
Empulse M90 is a medical device that received FDA 510(k) clearance on 2024-12-10. The listed applicant is Concourse Assistive Technology Pty, Ltd.. The 510(k) number is K242327.
When did Empulse M90 receive FDA 510(k) clearance?
Empulse M90 received FDA 510(k) clearance on 2024-12-10, under 510(k) number K242327.
Who is the listed applicant for Empulse M90?
The FDA 510(k) record lists Concourse Assistive Technology Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Empulse M90?
The FDA product code for Empulse M90 is ITI.
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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
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