K211346 is an FDA 510(k) clearance for the BLUE 400. This device is classified as a Diagnostic Neurosurgical Microscope Filter (Class II - Special Controls, product code QFX).
Submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on July 22, 2022, 445 days after receiving the submission on May 3, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4950. 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..
| 510(k) Number | K211346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2021 |
| Decision Date | July 22, 2022 |
| Days to Decision | 445 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | QFX — Diagnostic Neurosurgical Microscope Filter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4950 |
| Definition | 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. |