Sonoclot凝血与血小板功能分析仪系统，带Sonoclot查看器
K号: K223635 · 2023-01-04
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申请人Sienco, Inc.
决定日期2023-01-04
产品代码JBP
咨询委员会HE
请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。
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器械摘要
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Sienco, Inc.. It received FDA 510(k) clearance on 2023-01-04 under 510(k) number K223635. The device is classified under product code JBP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer?
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer is a medical device that received FDA 510(k) clearance on 2023-01-04. The listed applicant is Sienco, Inc.. The 510(k) number is K223635.
When did Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer receive FDA 510(k) clearance?
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer received FDA 510(k) clearance on 2023-01-04, under 510(k) number K223635.
Who is the listed applicant for Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer?
The FDA 510(k) record lists Sienco, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer?
The FDA product code for Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer is JBP.
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