FDA 510(k)

Slow Wave DS8

Número K: K191320 · 2020-10-02

Data da decisão2020-10-02

Código do produtoLQZ

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Slow Wave DS8 is the device name listed in this FDA 510(k) record. The listed applicant is Slow Wave, Inc.. It received FDA 510(k) clearance on 2020-10-02 under 510(k) number K191320. The device is classified under product code LQZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Slow Wave DS8?

Slow Wave DS8 is a medical device that received FDA 510(k) clearance on 2020-10-02. The listed applicant is Slow Wave, Inc.. The 510(k) number is K191320.

When did Slow Wave DS8 receive FDA 510(k) clearance?

Slow Wave DS8 received FDA 510(k) clearance on 2020-10-02, under 510(k) number K191320.

Who is the listed applicant for Slow Wave DS8?

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

What is the FDA product code for Slow Wave DS8?

The FDA product code for Slow Wave DS8 is LQZ.

Outros registros que listam Slow Wave, Inc. como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K240463Slow Wave DS8 (SWDS802)

Dispositivos Relacionados (Código: LQZ)

K233754AIO RespirarAiomega, LLC K230532RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC K203712The SlideBiotex, Inc.K192581The NightBlocks ApplianceAdvanced Facialdontics, LLC K162816SML-OSA2 AppliancesSelane Products, Inc.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.