FDA 510(k)

Comfort EC710

Número K: K163192 · 2017-04-10

RequerenteAlltech Medical Systems America, Inc.

Data da decisão2017-04-10

Código do produtoLNH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Comfort EC710 is the device name listed in this FDA 510(k) record. The listed applicant is Alltech Medical Systems America, Inc.. It received FDA 510(k) clearance on 2017-04-10 under 510(k) number K163192. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Comfort EC710?

Comfort EC710 is a medical device that received FDA 510(k) clearance on 2017-04-10. The listed applicant is Alltech Medical Systems America, Inc.. The 510(k) number is K163192.

When did Comfort EC710 receive FDA 510(k) clearance?

Comfort EC710 received FDA 510(k) clearance on 2017-04-10, under 510(k) number K163192.

Who is the listed applicant for Comfort EC710?

The FDA 510(k) record lists Alltech Medical Systems America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Comfort EC710?

The FDA product code for Comfort EC710 is LNH.

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