FDA 510(k)

PERIO-FLOW nozzle

Número K: K171174 · 2017-12-18

RequerenteE.M.S Electro Medical Systems S.A

Data da decisão2017-12-18

Código do produtoEFB

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

PERIO-FLOW nozzle 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 2017-12-18 under 510(k) number K171174. 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 PERIO-FLOW nozzle?

PERIO-FLOW nozzle is a medical device that received FDA 510(k) clearance on 2017-12-18. The listed applicant is E.M.S Electro Medical Systems S.A. The 510(k) number is K171174.

When did PERIO-FLOW nozzle receive FDA 510(k) clearance?

PERIO-FLOW nozzle received FDA 510(k) clearance on 2017-12-18, under 510(k) number K171174.

Who is the listed applicant for PERIO-FLOW nozzle?

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 PERIO-FLOW nozzle?

The FDA product code for PERIO-FLOW nozzle is EFB.

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