FDA 510(k)

Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets

Número K: K242660 · 2024-10-03

Data da decisão2024-10-03

Código do produtoFRN

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets is the device name listed in this FDA 510(k) record. The listed applicant is Zevex, Inc.. It received FDA 510(k) clearance on 2024-10-03 under 510(k) number K242660. 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 Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets?

Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets is a medical device that received FDA 510(k) clearance on 2024-10-03. The listed applicant is Zevex, Inc.. The 510(k) number is K242660.

When did Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets receive FDA 510(k) clearance?

Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets received FDA 510(k) clearance on 2024-10-03, under 510(k) number K242660.

Who is the listed applicant for Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets?

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

What is the FDA product code for Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets?

The FDA product code for Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets is FRN.

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Outros registros que listam Zevex, Inc. como candidato(a)

K232793Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets

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Fonte oficial

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