K240215 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 (Oberkochen, DE). The FDA issued a Cleared decision on June 28, 2024, 154 days after receiving the submission on January 26, 2024.
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 | K240215 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 2024 |
| Decision Date | June 28, 2024 |
| Days to Decision | 154 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. |