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FDA 510(k)

DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System

N.º K: K163054 · 2017-03-08

SolicitanteOsprey Medical, Inc.
Fecha de decisión2017-03-08
Código de productoDXT
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Osprey Medical, Inc.. It received FDA 510(k) clearance on 2017-03-08 under 510(k) number K163054. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System?

DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System is a medical device that received FDA 510(k) clearance on 2017-03-08. The listed applicant is Osprey Medical, Inc.. The 510(k) number is K163054.

When did DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System receive FDA 510(k) clearance?

DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System received FDA 510(k) clearance on 2017-03-08, under 510(k) number K163054.

Who is the listed applicant for DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System?

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

What is the FDA product code for DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System?

The FDA product code for DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System is DXT.

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Otros registros que enlistan a Osprey Medical, Inc. como solicitante

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K190102DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction SystemK183267DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction SystemK181936DyeVert PLUS EZ Contrast Reduction SystemK171698Smart SyringeK171217DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemK161505DyeVert NG Contrast Modulation System

Ver todos los 8 dispositivos →

Dispositivos relacionados (Código: DXT)

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.

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Fuente oficial

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