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FDA 510(k)

Saranas Early Bird Bleed Monitoring System

Número K: K230273 · 2023-05-25

RequerenteSaranas, Inc.
Data da decisão2023-05-25
Código do produtoQFJ
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Saranas Early Bird Bleed Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Saranas, Inc.. It received FDA 510(k) clearance on 2023-05-25 under 510(k) number K230273. The device is classified under product code QFJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Saranas Early Bird Bleed Monitoring System?

Saranas Early Bird Bleed Monitoring System is a medical device that received FDA 510(k) clearance on 2023-05-25. The listed applicant is Saranas, Inc.. The 510(k) number is K230273.

When did Saranas Early Bird Bleed Monitoring System receive FDA 510(k) clearance?

Saranas Early Bird Bleed Monitoring System received FDA 510(k) clearance on 2023-05-25, under 510(k) number K230273.

Who is the listed applicant for Saranas Early Bird Bleed Monitoring System?

The FDA 510(k) record lists Saranas, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Saranas Early Bird Bleed Monitoring System?

The FDA product code for Saranas Early Bird Bleed Monitoring System is QFJ.

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