FDA 510(k)

OW100S

N.º K: K233937 · 2024-07-09

Fecha de decisión2024-07-09

Código de productoPZL

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Otros registros que enlistan a Softwave/Trt, LLC como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.