FDA 510(k)

AposTherapy System

Número K: K182090 · 2018-11-16

Data da decisão2018-11-16

Código do produtoQDT

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

AposTherapy System is the device name listed in this FDA 510(k) record. The listed applicant is Apos Medical Assets , Ltd.. It received FDA 510(k) clearance on 2018-11-16 under 510(k) number K182090. The device is classified under product code QDT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AposTherapy System?

AposTherapy System is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is Apos Medical Assets , Ltd.. The 510(k) number is K182090.

When did AposTherapy System receive FDA 510(k) clearance?

AposTherapy System received FDA 510(k) clearance on 2018-11-16, under 510(k) number K182090.

Who is the listed applicant for AposTherapy System?

The FDA 510(k) record lists Apos Medical Assets , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AposTherapy System?

The FDA product code for AposTherapy System is QDT.

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