Sonoclot 凝血與血小板功能分析系統，搭配 Sonoclot 觀察器
K 號：K223635 · 2023-01-04
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器材摘要
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.
常見問題
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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官方來源
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