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FDA 510(k)

Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter

Número K: K231918 · 2023-11-03

RequerenteKoru Medical Systems
Data da decisão2023-11-03
Código do produtoFRN
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Koru Medical Systems. It received FDA 510(k) clearance on 2023-11-03 under 510(k) number K231918. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter?

Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter is a medical device that received FDA 510(k) clearance on 2023-11-03. The listed applicant is Koru Medical Systems. The 510(k) number is K231918.

When did Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter receive FDA 510(k) clearance?

Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter received FDA 510(k) clearance on 2023-11-03, under 510(k) number K231918.

Who is the listed applicant for Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter?

The FDA 510(k) record lists Koru Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter?

The FDA product code for Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter is FRN.

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Dispositivos Relacionados (Código: FRN)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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