FDA 510(k)

AIR-FLOW handy 3.0 PLUS

Número K: K151912 · 2016-02-03

RequerenteE.M.S Electro Medical Systems S.A

Data da decisão2016-02-03

Código do produtoEFB

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

AIR-FLOW handy 3.0 PLUS is the device name listed in this FDA 510(k) record. The listed applicant is E.M.S Electro Medical Systems S.A. It received FDA 510(k) clearance on 2016-02-03 under 510(k) number K151912. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AIR-FLOW handy 3.0 PLUS?

AIR-FLOW handy 3.0 PLUS is a medical device that received FDA 510(k) clearance on 2016-02-03. The listed applicant is E.M.S Electro Medical Systems S.A. The 510(k) number is K151912.

When did AIR-FLOW handy 3.0 PLUS receive FDA 510(k) clearance?

AIR-FLOW handy 3.0 PLUS received FDA 510(k) clearance on 2016-02-03, under 510(k) number K151912.

Who is the listed applicant for AIR-FLOW handy 3.0 PLUS?

The FDA 510(k) record lists E.M.S Electro Medical Systems S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIR-FLOW handy 3.0 PLUS?

The FDA product code for AIR-FLOW handy 3.0 PLUS is EFB.

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Fonte oficial

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