FDA 510(k) clearance · back to tracker

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

Schoelly Fiberoptic GmbH cleared K233225 on 2024-06-20, decision: substantially equivalent

K-number

K233225

Sponsor

Schoelly Fiberoptic GmbH

Device

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

Class

Class II

Decision

Substantially Equivalent

Decision date

2024-06-20

Product code

GCJ

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.1500

Official FDA record

Open K233225on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.