CMOS Video Nasopharyngoscope System— 510(k) K143673
Substantially EquivalentSchoelly Fiberoptic GmbH
FDA 510(k) clearance K143673 for CMOS Video Nasopharyngoscope System, Substantially Equivalent on 2015-03-04. Applicant: Schoelly Fiberoptic GmbH. Device class: 2.
Clearance details
- Applicant
- Schoelly Fiberoptic GmbH
- Product code
- Code EOB
- Device class
- Class 2
- Regulation
- 21 CFR 874.4760
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Denzlingen, DE
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More clearances from Schoelly Fiberoptic GmbH
view all- K233225 — SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)
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- K201970 — Schoelly Cystoscopes/Hysteroscopes and Accessories
- K151308 — Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
Adverse events under product code EOB
product code EOB- Malfunction
- 6,143
- Total
- 6,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.