FDA 510(k)

TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))

N.º K: K201617 · 2021-03-12

Fecha de decisión2021-03-12

Código de productoHET

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) is the device name listed in this FDA 510(k) record. The listed applicant is Schoelly Fiberoptic GmbH. It received FDA 510(k) clearance on 2021-03-12 under 510(k) number K201617. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))?

TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) is a medical device that received FDA 510(k) clearance on 2021-03-12. The listed applicant is Schoelly Fiberoptic GmbH. The 510(k) number is K201617.

When did TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) receive FDA 510(k) clearance?

TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) received FDA 510(k) clearance on 2021-03-12, under 510(k) number K201617.

Who is the listed applicant for TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))?

The FDA 510(k) record lists Schoelly Fiberoptic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))?

The FDA product code for TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) is HET.

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Otros registros que enlistan a Schoelly Fiberoptic GmbH como solicitante

K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source K201970Schoelly Cystoscopes/Hysteroscopes and Accessories K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set

Dispositivos relacionados (Código: HET)

K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) Limited K243821i-CutA.M.I. Agency For Medical Innovations GmbH K221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) Limited K210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope System270surgical , Ltd.

Fuente oficial

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