FDA 510(k)

Transcend 365 miniCPAP System

Número K: K180388 · 2018-11-30

Data da decisão2018-11-30

Código do produtoBZD

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Transcend 365 miniCPAP System is the device name listed in this FDA 510(k) record. The listed applicant is Somnetics International, Inc.. It received FDA 510(k) clearance on 2018-11-30 under 510(k) number K180388. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Transcend 365 miniCPAP System?

Transcend 365 miniCPAP System is a medical device that received FDA 510(k) clearance on 2018-11-30. The listed applicant is Somnetics International, Inc.. The 510(k) number is K180388.

When did Transcend 365 miniCPAP System receive FDA 510(k) clearance?

Transcend 365 miniCPAP System received FDA 510(k) clearance on 2018-11-30, under 510(k) number K180388.

Who is the listed applicant for Transcend 365 miniCPAP System?

The FDA 510(k) record lists Somnetics International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transcend 365 miniCPAP System?

The FDA product code for Transcend 365 miniCPAP System is BZD.

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