510(k) K211346
K211346 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, AG for the device "BLUE 400". The FDA issued a decision of Substantially Equivalent on July 22, 2022. The device falls under product code QFX (Diagnostic Neurosurgical Microscope Filter), a Class II device regulated under 21 CFR 882.4950. Carl Zeiss Meditec, AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2022
- Date Received
- May 3, 2021
- Clearance Type
- Traditional
- 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.