FDA 510(k)

Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source

Numéro K : K221591 · 2023-02-23

Date de décision2023-02-23

Code produitGCJ

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source 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 2023-02-23 under 510(k) number K221591. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source?

Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Schoelly Fiberoptic GmbH. The 510(k) number is K221591.

When did Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source receive FDA 510(k) clearance?

Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source received FDA 510(k) clearance on 2023-02-23, under 510(k) number K221591.

Who is the listed applicant for Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source?

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 Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source?

The FDA product code for Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source is GCJ.

Essais cliniques associés

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Autres dossiers indiquant Schoelly Fiberoptic GmbH en tant que demandeur

K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))K201970Schoelly Cystoscopes/Hysteroscopes and Accessories K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set

Dispositifs connexes (Code : GCJ)

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Source officielle

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