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FDA 510(k)

Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer

Número K: K223635 · 2023-01-04

RequerenteSienco, Inc.
Data da decisão2023-01-04
Código do produtoJBP
Comité consultivoHE
DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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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Fonte oficial

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