FDA 510(k)

EasyPoint Blood Collection Plus

Número K: K202325 · 2021-04-09

RequerenteRetractable Technologies, Inc.

Data da decisão2021-04-09

Código do produtoJKA

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

EasyPoint Blood Collection Plus is the device name listed in this FDA 510(k) record. The listed applicant is Retractable Technologies, Inc.. It received FDA 510(k) clearance on 2021-04-09 under 510(k) number K202325. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EasyPoint Blood Collection Plus?

EasyPoint Blood Collection Plus is a medical device that received FDA 510(k) clearance on 2021-04-09. The listed applicant is Retractable Technologies, Inc.. The 510(k) number is K202325.

When did EasyPoint Blood Collection Plus receive FDA 510(k) clearance?

EasyPoint Blood Collection Plus received FDA 510(k) clearance on 2021-04-09, under 510(k) number K202325.

Who is the listed applicant for EasyPoint Blood Collection Plus?

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

What is the FDA product code for EasyPoint Blood Collection Plus?

The FDA product code for EasyPoint Blood Collection Plus is JKA.

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Fonte oficial

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