Coaptium Connect with Tissium Light
K号: K251957 · 2025-09-08
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申请人Tissium SA
决定日期2025-09-08
产品代码SFD
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
Coaptium Connect with Tissium Light is the device name listed in this FDA 510(k) record. The listed applicant is Tissium SA. It received FDA 510(k) clearance on 2025-09-08 under 510(k) number K251957. The device is classified under product code SFD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Coaptium Connect with Tissium Light?
Coaptium Connect with Tissium Light is a medical device that received FDA 510(k) clearance on 2025-09-08. The listed applicant is Tissium SA. The 510(k) number is K251957.
When did Coaptium Connect with Tissium Light receive FDA 510(k) clearance?
Coaptium Connect with Tissium Light received FDA 510(k) clearance on 2025-09-08, under 510(k) number K251957.
Who is the listed applicant for Coaptium Connect with Tissium Light?
The FDA 510(k) record lists Tissium SA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Coaptium Connect with Tissium Light?
The FDA product code for Coaptium Connect with Tissium Light is SFD.
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