510(k) K120208
K120208 is an FDA 510(k) premarket notification submitted by Mauna Kea Technologies for the device "CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES". The FDA issued a decision of Substantially Equivalent on April 20, 2012. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500. Mauna Kea Technologies has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 2012
- Date Received
- January 24, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Confocal Optical Imaging
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- SU
- Submission Type
Collection of light signals for visualization of cellular microstructures.