510(k) K190449
K190449 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head". The FDA issued a decision of Substantially Equivalent on Aug 30, 2019. The device falls under product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Olympus Medical Systems Corp. has 103 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 30, 2019
- Date Received
- Feb 25, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
- 510(k)
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.