FDA 510(k)

Insignis™ Syringe Infusion System

Número K: K232328 · 2024-03-01

RequerenteInnovative Health Sciences, LLC

Data da decisão2024-03-01

Código do produtoFPA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Insignis™ Syringe Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health Sciences, LLC. It received FDA 510(k) clearance on 2024-03-01 under 510(k) number K232328. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Insignis™ Syringe Infusion System?

Insignis™ Syringe Infusion System is a medical device that received FDA 510(k) clearance on 2024-03-01. The listed applicant is Innovative Health Sciences, LLC. The 510(k) number is K232328.

When did Insignis™ Syringe Infusion System receive FDA 510(k) clearance?

Insignis™ Syringe Infusion System received FDA 510(k) clearance on 2024-03-01, under 510(k) number K232328.

Who is the listed applicant for Insignis™ Syringe Infusion System?

The FDA 510(k) record lists Innovative Health Sciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Insignis™ Syringe Infusion System?

The FDA product code for Insignis™ Syringe Infusion System is FPA.

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Outros registros que listam Innovative Health Sciences, LLC como candidato(a)

K202279Insignis Subcutaneous Needle Sets

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Fonte oficial

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