FDA 510(k)

SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)

Numéro K : K233225 · 2024-06-20

Date de décision2024-06-20

Code produitGCJ

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) 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 2024-06-20 under 510(k) number K233225. 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 SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)?

SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) is a medical device that received FDA 510(k) clearance on 2024-06-20. The listed applicant is Schoelly Fiberoptic GmbH. The 510(k) number is K233225.

When did SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) receive FDA 510(k) clearance?

SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) received FDA 510(k) clearance on 2024-06-20, under 510(k) number K233225.

Who is the listed applicant for SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)?

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 SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)?

The FDA product code for SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) is GCJ.

Essais cliniques associés

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Autres dossiers indiquant Schoelly Fiberoptic GmbH en tant que demandeur

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Dispositifs connexes (Code : GCJ)

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Source officielle

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