510(k) DEN180024
DEN180024 is an FDA 510(k) premarket notification submitted by Leica Microsystems (Schweiz) AG for the device "Leica FL400". The FDA issued a decision of De Novo Granted on March 28, 2019. The device falls under product code QFX (Diagnostic Neurosurgical Microscope Filter), a Class II device regulated under 21 CFR 882.4950. Leica Microsystems (Schweiz) AG has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 28, 2019
- Date Received
- April 27, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Diagnostic Neurosurgical Microscope Filter
- Device Class
- Class II
- Regulation Number
- 882.4950
- Review Panel
- NE
- Submission Type
A diagnostic neurosurgical microscope filter is a device intended for use during neurosurgery to visualize fluorescence and enhance visualization of tissue associated with a specific disease or condition.