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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233225
510(k) Type
Traditional
Applicant
Schoelly Fiberoptic GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
6/20/2024
Days to Decision
266 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233225
510(k) Type
Traditional
Applicant
Schoelly Fiberoptic GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
6/20/2024
Days to Decision
266 days
Submission Type
Summary