Cleared Traditional

BLUE 400

K211346 · Carl Zeiss Meditec, AG · Neurology
Jul 2022
Decision
445d
Days
Class 2
Risk

About This 510(k) Submission

K211346 is an FDA 510(k) clearance for the BLUE 400, 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 review panel. Regulated under 21 CFR 882.4950.

Submission Details

510(k) Number K211346 FDA.gov
FDA Decision Cleared 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

Device Classification

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.