510(k) K191851
K191851 is an FDA 510(k) premarket notification submitted by Medtronic for the device "VS3-IR". The FDA issued a decision of Substantially Equivalent on Nov 25, 2019. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500. Medtronic has 247 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 25, 2019
- Date Received
- Jul 10, 2019
- Clearance Type
- Traditional
- 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
- 510(k)
Collection of light signals for visualization of cellular microstructures.