SACS PRO
K号: K243177 · 2024-12-23
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决定日期2024-12-23
产品代码IRP
咨询委员会PM
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决定实质等同
器械摘要
SACS PRO is the device name listed in this FDA 510(k) record. The listed applicant is Elastimed , Ltd.. It received FDA 510(k) clearance on 2024-12-23 under 510(k) number K243177. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SACS PRO?
SACS PRO is a medical device that received FDA 510(k) clearance on 2024-12-23. The listed applicant is Elastimed , Ltd.. The 510(k) number is K243177.
When did SACS PRO receive FDA 510(k) clearance?
SACS PRO received FDA 510(k) clearance on 2024-12-23, under 510(k) number K243177.
Who is the listed applicant for SACS PRO?
The FDA 510(k) record lists Elastimed , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SACS PRO?
The FDA product code for SACS PRO is IRP.
列明Elastimed , Ltd.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：IRP）
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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