FDA 510(k)

Sienna Ultimate Wireless Amplifier

Número K: K171397 · 2017-10-06

RequerenteEms Handels Gesellschaft M.B.H.

Data da decisão2017-10-06

Código do produtoGWL

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sienna Ultimate Wireless Amplifier is the device name listed in this FDA 510(k) record. The listed applicant is Ems Handels Gesellschaft M.B.H.. It received FDA 510(k) clearance on 2017-10-06 under 510(k) number K171397. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sienna Ultimate Wireless Amplifier?

Sienna Ultimate Wireless Amplifier is a medical device that received FDA 510(k) clearance on 2017-10-06. The listed applicant is Ems Handels Gesellschaft M.B.H.. The 510(k) number is K171397.

When did Sienna Ultimate Wireless Amplifier receive FDA 510(k) clearance?

Sienna Ultimate Wireless Amplifier received FDA 510(k) clearance on 2017-10-06, under 510(k) number K171397.

Who is the listed applicant for Sienna Ultimate Wireless Amplifier?

The FDA 510(k) record lists Ems Handels Gesellschaft M.B.H. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sienna Ultimate Wireless Amplifier?

The FDA product code for Sienna Ultimate Wireless Amplifier is GWL.

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