FDA 510(k)

Seal Rite Non-Rebreathing Valve

Número K: K152521 · 2016-06-03

Data da decisão2016-06-03

Código do produtoCBP

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Seal Rite Non-Rebreathing Valve is the device name listed in this FDA 510(k) record. The listed applicant is The Lifeguard Store, Inc.. It received FDA 510(k) clearance on 2016-06-03 under 510(k) number K152521. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Seal Rite Non-Rebreathing Valve?

Seal Rite Non-Rebreathing Valve is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is The Lifeguard Store, Inc.. The 510(k) number is K152521.

When did Seal Rite Non-Rebreathing Valve receive FDA 510(k) clearance?

Seal Rite Non-Rebreathing Valve received FDA 510(k) clearance on 2016-06-03, under 510(k) number K152521.

Who is the listed applicant for Seal Rite Non-Rebreathing Valve?

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

What is the FDA product code for Seal Rite Non-Rebreathing Valve?

The FDA product code for Seal Rite Non-Rebreathing Valve is CBP.

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