FDA PMA

System, oxygen, aqueous

Número do PMA: P170027 · 2026-04-10

RequerenteZoll Circulation, Inc.

Data da decisão2026-04-10

Número PMAP170027

Código do produtoMWG

Classe do DispositivoClasse 3

Especialidade MédicaU

Comité consultivoCV

Resumo do dispositivo

System, oxygen, aqueous is the device name listed in this FDA 510(k) record. The listed applicant is Zoll Circulation, Inc.. It received FDA 510(k) clearance on 2026-04-10. The device is classified under product code MWG. It was reviewed by the CV advisory panel.

Perguntas frequentes

What is the System, oxygen, aqueous?

System, oxygen, aqueous is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Zoll Circulation, Inc..

When did System, oxygen, aqueous receive FDA 510(k) clearance?

The clearance date for System, oxygen, aqueous can be found in the official FDA records.

Who is the listed applicant for System, oxygen, aqueous?

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

What is the FDA product code for System, oxygen, aqueous?

The FDA product code for System, oxygen, aqueous is MWG.

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Fonte oficial

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