FDA 510(k)

ProntoPump Sterile Tube Set

Número K: K200893 · 2021-05-04

Data da decisão2021-05-04

Código do produtoLHI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

ProntoPump Sterile Tube Set is the device name listed in this FDA 510(k) record. The listed applicant is Ipax, Inc.. It received FDA 510(k) clearance on 2021-05-04 under 510(k) number K200893. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ProntoPump Sterile Tube Set?

ProntoPump Sterile Tube Set is a medical device that received FDA 510(k) clearance on 2021-05-04. The listed applicant is Ipax, Inc.. The 510(k) number is K200893.

When did ProntoPump Sterile Tube Set receive FDA 510(k) clearance?

ProntoPump Sterile Tube Set received FDA 510(k) clearance on 2021-05-04, under 510(k) number K200893.

Who is the listed applicant for ProntoPump Sterile Tube Set?

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

What is the FDA product code for ProntoPump Sterile Tube Set?

The FDA product code for ProntoPump Sterile Tube Set is LHI.

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