FDA 510(k)

OW100S

Número K: K233937 · 2024-07-09

Data da decisão2024-07-09

Código do produtoPZL

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

OW100S is the device name listed in this FDA 510(k) record. The listed applicant is Softwave/Trt, LLC. It received FDA 510(k) clearance on 2024-07-09 under 510(k) number K233937. The device is classified under product code PZL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OW100S?

OW100S is a medical device that received FDA 510(k) clearance on 2024-07-09. The listed applicant is Softwave/Trt, LLC. The 510(k) number is K233937.

When did OW100S receive FDA 510(k) clearance?

OW100S received FDA 510(k) clearance on 2024-07-09, under 510(k) number K233937.

Who is the listed applicant for OW100S?

The FDA 510(k) record lists Softwave/Trt, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OW100S?

The FDA product code for OW100S is PZL.

Outros registros que listam Softwave/Trt, LLC 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.

K231710OW100S

Dispositivos Relacionados (Código: PZL)

K243279DOLORCLAST Focused Shock WavesE.M.S Electro Medical Systems S.A K250779CS-Pro MEDCurative Sound Therapeutics K231710OW100SSoftwave/Trt, LLC K202112Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia HandpieceStorz Medical AG K200926OrthoGold 100Tissue Regeneration Technologies, LLC K191961OrthoGoldTissue Regeneration Technologies

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.